Recalls, Safety & Important Product Information

5/25/2018 3:26 PM
Recalls & Safety Information -
Click HERE to access recalls from 2015 in the 2015 Money Maker publications
F.D.A. Alerts 
 
5/25/2018
1. Aurobindo has issued a notification for discrepancy in the patient information leaflet for select batches of Tenofovir Disoproxil Fumarate 300 mg tablets. There is no impact on product efficacy and patient safety. 
 
5/18/2018
1. Perrigo is initiating a retail level recall on eighteen (18) batches of Scopolamine 1mg/72hr Transdermal Patches currently in the marketplace. 
2. Roche has identified four test strip lots that are out of specification. The affected test strips were found to have cracked reagent which may cause them to become defective.
 
5/11/2018
1. Noven Pharmaceuticals has issued an urgent recall for four lots of Minivelle Transdermal Patches. This recall has been initiated due to out-of-specification test results related to the adhesive properties of the patches.
2. BD has updated its voluntarily recall of certain lots of BD PosiFlush Heparin Lock Flush and BD Pre-Filled Normal Saline Flush Syringes due to a potential for contamination.
 
5/4/2018
1. Exela Pharma Science is voluntarily recalling Diclofenac Sodium and Misoprostol Delayed Release Tablets 50/0.2mg and Diclofenac Sodium and Misoprostol Delayed Release Tablets 75/0.2mg distributed under the Eagle Pharmaceuticals label and manufactured by Cipla Ltd.
 
4/26/2018
1. BD is voluntarily recalling certain lots of BD PosiFlush Heparin Lock Flush and BD Pre-Filled Normal Saline Flush Syringes due to a potential for contamination. 
 
4/13/2018
1. Contract Pharmacal Corp, on behalf of Major Pharmaceuticals has initiated a voluntary retail level recall for FeroSul (Ferrous Sulfate).
2. Akorn has initiated a recall, to the retail level, for Chlorhexidine Gluconate Oral Rinse 0.12% (Unit Dose Cups), Halyard 24-Hour Oral Care Q2 & Q4 Kit with CHG
3. Noven Pharmaceuticals has initiated a recall, to the retail level, for one lot of Daytrana Patches.
 
3/22/2018
1. Teva is voluntarily recalling the several lots of Estradiol Vaginal Inserts, USP 10mcg distributed under the Teva Woman’s Health label. 
2. Glenmark has initiated a voluntary recall for Indomethacin Capsules 50mg in the 100 count bottle. 
3. InvaGen Pharmaceuticals, Inc. is recalling Bupropion HC1 Extented Release Tablets 100mg
 
3/16/2018
InvaGen Pharmaceuticals is recalling Bupropion HC1 Extended Release Tablets 100mg.
 
3/9/2018
3M has initiated a retail level recall for Ace Brand Deluxe Ankle Brace.
 
3/6/2018
Akorn recalls one lot to the retail level of Atropine Sulfate Ophthalmic 1% Solution 5ml Bottle.
 
3/5/2018
Allergan has initiated a voluntary market withdrawal of six lots of Scandishake.
 
2/27/2018
Perrigo recalls one batch of Perrigo Evamist Transdermal Spray distributed between the dates of 8/17/17-1/3/18.
 
2/16/2018
Additional lot numbers are added to Allergan’s voluntary recall, to the retail level, of INFed (Iron Dextran Injection, USP).
 
2/15/2018
Nostrum Laboratories Inc. recalls one lot of Calcium Acetate Capsules, 667 mg.
Genentech USA, Inc. recalls one lot of Klonopin Tablets (clonazepam) 0.5mg 100 ct bottle.
 
2/7/2018
Teva Pharmaceuticals USA, Inc. recalls all lots within expiry of Fluoxetine Tablets USP, 10mg 30 count bottles only, distributed under the Teva Pharmaceuticals label.
 
2/6/2018
Unichem Pharmaceuticals recalls one lot of Divalproex Sodium DR Tablets 500mg.
Allergan recalls one lot of Norco 10/325mg, Hydrocodone Bitartrate and Acetaminophen Tablets USP.
 
2/5/2018
Aurobindo Pharma recalls one lot of Metformin Hydrochloride.
 
2/2/2018
Teva Pharmaceuticals USA, Inc. recalls all lots within expiry of Fentanyl Transdermal System CII, 25 mcg/h, 50 mcg/h, 75 mcg/h and 100 mcg/h distributed under the Actavis Pharma Inc. label.
 
2/1/2018
Primus Pharmaceuticals recalls multiple lots of Limbrel products to the consumer level. 
 
1/19/2018
Allergan recalls multiple lots of INFed (Iron Dextran Injection, USP).
 
12/27/2017
 
12/20/2017
Akorn, Inc.recalls one lot of Gabapentin Oral Solution.
 
12/15/2017
 
12/8/2017
Bard Medical labeling issue on Skin Protectant Prep Pads. This is not a recall.
 
12/6/2017
Mayne Pharma is recalling one lot of Liothyronine Sodium Tablets, USP, 25mcg 100 count bottles to the retail level.
 
12/5/2017
Allergan recalls one lot of Viokace® 20,880 USP Units.
 
11/30/2017
Teva is voluntarily recalling one lot of PENICILLIN V POTASSIUM for Oral Solution USP, 125 mg (200,000 U) per 5 mL distributed under the Teva Pharmaceuticals label.
 
11/22/2017
Zydus Pharmaceuticals recalls three lots of Paroxetine 30 mg tab.
Teva recalls one lot of Amethyst™ (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg) distributed under the Actavis Pharma Inc. label.
 
11/20/2017
Greenstone LLC, recalls multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level.
 
11/14/2017
Bayer, in consultation with the U.S. Food and Drug Administration (FDA), is recalling to the RETAIL LEVEL on one lot of Bayer Chewable Aspirin 81mg (orange flavor) due to a stability test result which did not meet predefined specifications.
 
11/13/2017
Teva Pharmaceuticals USA, Inc. recalls to the RETAIL LEVEL the below lot of Clozapine Tablets USP, 100 mg distributed under the Teva Pharmaceuticals label.
 
11/7/2017
Owen Mumford is issuing a voluntary recall for one lot of Unifine Pentips 5mm pen needles.
 
11/3/2017
Cardinal Health is recalling a production lot of ARGYLE SUCTION TUBING. As of July 29, 2017 Cardinal Health acquired this product line from Medtronic, and is initiating
this recall of the Covidien Product.
 
10/29/2017
Greenstone LLC, is recalling the lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP, to the retail level.
 
10/27/2017
Baxter Safety Alert on 0.9% Sodium Chloride Inj USP 100 mL VIAFLEX Plastic Container Quad Pack
 
10/26/2017
Teva recalls all lots of Dutasteride and Tamsulosin HCI Capsules 0.5mg/0.4mg distributed under the Actavis Pharma, Inc. label.
 
10/25/2017
 
10/24/2017
Allergan recalls seven lots of COMBIGAN 0.2/0.5 and One lot of LUMIGAN 0.01.
 
10/18/2017
Teva Pharmaceuticals USA, Inc. recalls one lot of Methylphenidate Hydrochloride Tablets USP, 20mg, 100 count bottles distributed under the Watson Laboratories, Inc. label.
 
Unichem Pharmaceuticals recalls lots of Bisoprolol Fumarate tablets 5 mg.
 
10/17/2017
New! Dr. Reddy's recalls lots of Doan's Pain Relieving Cream with Lidocaine.
 
10/9/2017
Bard recalls specific lots of Magic3®, HydroSil Gripper (EU only), and Personal Intermittent Catheters (16” and 10” lengths).
 
10/2/2017
Medtronic is conducting, to the Consumer level, a voluntary product recall of specific lots of infusion sets used with Medtronic insulin pumps.
 
9/21/2017
Solu-Medrol has a drug warning concerning possible allergy to cow's milk
 
9/20/2017
Independence Medical has issued a voluntary recall to the retail level, one lot of Flextend Skin Barrier with tape border.
 
9/19/2017
Jansen recall specific lots of PROCRIT 1mL Single Dose, Preservative free Solution
 
9/5/2017
Retail level recall of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 250/62.5 mg per 5 mL and manufactured for Morton Grove Pharmaceuticals, Inc.
 
BD is expanding the product removal recall of the BD Insulin Syringes with the BD Ultra-Fine™ needle ½ ml 12.7mm 30G, Cat (Ref) 328466, to include more lots.
 
9/1/2017
NOVEN THERAPEUTICS LLC is conducting a voluntary product recall to the RETAIL LEVEL for the six (6) lot numbers of DAYTRANA.
 
8/25/2017
Centurion Labs recalls Ninjacof products manufactured by Vilvet (Dania Beach, FL), to the Retail Level due to potential contamination with Burkholderia cepacia.
 
8/24/17
Wockhardt recalls lots of Enalapril tablets USP 2.5 mg and 5 mg.
 
8/21/17
Zydus Pharmaceuticals USA Inc. recalls one lot of Paroxetine.
 
8/15/2017
PharmTech recalls multiple products.
 
8/9/2017
Pfizer Inc recalls lots of Quillivant XR® (methylphenidate HCI) for extended-release oral suspension.
 
8/7/2017
Pharma Tech recalls two DIOCTO products.
 
8/3/2017
Teva recalls one lot of GlipiZIDE Extended-Release Tablets, 5 mg, Unit Dose Blister Packs distributed under Watson label.
 
7/31/2017
Bayer is recalling ten lots of certain Alka-Seltzer® effervescent products distributed between May 24, 2016 and January 24, 2017 due to a packaging component issue.
 
7.27.2017
Teva Pharmaceuticals recalls one lot of Famotidine Tablets USP, 20 mg, 100 Count Bottles
 
7.26.2017
Teva recalls to the RETAIL LEVEL All Lots Within Expiry of Albuterol Sulfate Inhalation Solution. 0.021% (0.63 mg/3 mL) which is distributed under the Watson Laboratories Inc. label.
 
7/11/2017
NovoNordisk recalls batches of Novo Pen Echo.
 
7/3/2017
Teva Pharmaceuticals USA, Inc. recalls all lots of Buprenorphine and Naloxone Sublingual Tablets 8mg/2mg and 2mg/0.5mg distributed under the Teva Pharmaceuticals label.
 
6/21/2017
Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets UPDATE recall is to the retail/dispensing level
 
6/15/2017
Bristol-Myers Squibb Company has elevated recall, to the consumer level, of one lot of Eliquis 5 mg tablets.
 
6/8/201
Medtech Products, Inc recalls one lot of NasalCrom Nasal Spray.
 
6/7/2017
Bristol-Myers Squibb Company recalls one lot of Eliquis 5 mg tablets.
 
6/5/2017
Teva Pharmaceuticals is recalling one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles distributed under the Actavis label.
 
5/31/2017
BD recalls one lot of insulin syringes with BD Ultra-fine needle 1/2 mL 12.7 mm 30G Cat Ref328466.
 
5/30/2017
Lupin Pharmaceuticals recalls one lot of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg). 
 
5/24/2017
Dr. Reddy’s Laboratories, Inc extends recall to the retail level, of the attached lots of Zenatane (Isotretinoin Capsules USP); this recall is an extension to the recall which was initiated in February 2017.
 
5/22/2017
GlaxoSmithKline (GSK) initiated a voluntary recall for three lots Ventolin HFA Inhalers to the  RETAIL level. This recall was initiated due to an elevated number of units with our of specification results for leak rate. The recall has been expanded to include three additional lot numbers.
 
5/19/2017
Allergan recalls two lots of SAPHRIS 10 mg.
 
5/17/2017
Allergan recalls one lot of BLEPHAMIDE 10%/0.2%, 3.5g.
 
5/12/2017
HoMedics is recalling to the retail level, Homedics Hand Held Massagers Model numbers HHP-250, HHP-375H and PA-MH-THP.
 
5/9/2017
Nature's Truth updates Slow Release Iron Tablet recall. Also a poster is now available for download for stores.
 
5/2/2017
Taro Pharmaceuticals USA, Inc. recalls lots of Nystatin and Triamcinolone Acetonide Cream, USP 100,000 units/1mg/g packaged in 15g, 30g, and 60g tubes.
 
4/27/2017
Teva recalls lots of Clozapine Tablets USP, 25 mg. 
 
4/21/2017
Sun Pharmaceuticals recalls lots of Metformin Hydrochloride Oral Solution.
 
4/4/2017
NuGo Nutrition has issued a voluntary recall for Slim Crunchy Peanut Butter.
Nature's Truth recalls two lots of Slow Release Iron Tablets.
 
4/3/2017
Mylan expanded recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S.
 
3/30/2017
Sandoz Inc., as a distributor, on behalf of Novartis Pharmaceuticals Corporation, recalls the below lot of Pilocarpine Hydrochloride Ophthalmic Solution 4% 15 mL Bottle.
 
3/29/2017
Homedics recalls Hand Held Massager.
Teva recalls lots of PrednisoLONE Oral Solution USP, 15 mg/5 mL distributed under the Teva Pharmaceuticals label.
 
3/27/2017
ALERT: Faxed-based phishing scam targeting Pharmacies. The Drug Enforcement Administration (DEA) has received notification of a faxed-based phishing scam.
The DEA urges registered Pharmacies to be on guard against a fax asking for licensing information. The DEA is continuously identifying safeguards against suspicious activity, but cybercriminals are ever evolving with identity theft scams.

For example, attached is a sample fax requesting Pharmacies to provide a copy of the current DEA certificate and State license. If anyone has already provided this information,the DEA urges the registrant to contact their local field office.

Registrants who receive information that seems suspicious should forward them to: DEA.Validation@usdoj.gov

Also, the DEA does not send unsolicited faxes or emails requesting sensitive data.

 
 
3/27/2017
GlaxoSmithKline (GSK) recalls lots of Ventolin HFA Inhaler.
 
3/22/2017
Fresenius Kabi USA (formerly APP Pharmaceuticals) is voluntarily recalling batches of Fluphenazine Decanoate Injection, USP 25 mg / mL, 5 mL fill in a 5 mL vial.
Allergan recalls one lot of LUMIGAN® 0.01%, 7.5 mL.
 
3/16/2017
Medtronic recalls various Covidien Curity eye pads and dressings.
 
3/13/2017
Dr. Reddy’s Laboratories, Inc recalls one lot of Rivastigmine Tartrate Capsules USP 1.5mg.
 
3/10/2017
 
3/7/2017
Zydus Pharmaceuticals recalls lots of Atenolol Tablets, 50 mg.
 
2/27/2017
Citron Pharma is recalling one lot of Penicillin V Potassium Tablets, 500 mg
 
2/24/2017
Bayer, in consultation with the U.S. Food and Drug Administration (FDA) recalls  38 lots of A+D Diaper Rash Cream due to a label claim issue.
 
2/21/2017
Teva Pharmaceuticals USA, Inc. recalls lot of Risedronate Sodium Delayed-release Tablets, 35 mg.
 
2/17/2017
Dr. Reddy’s Laboratories, Inc recalls lots of Zenatane (Isotretinoin Capsules USP).
 
2/16/2017
Allegiant is recalling one lot of Aspirin 81mg Chewable Tablets.
 
2/13/2017
Colgate recalls lots of Prevident 5000 Dry Mouth Toothpaste.
 
2/8/2017
Teva Pharmaceuticals USA, Inc. recalls one lot of Buprenorphine and Naloxone Sublingual Tablets 8mg/2mg.
 
2/6/2017
Apotex Corp. recalls one lot of CycloSPORINE Capsules, USP.
 
2/3/2017
Sandoz Inc. (“Sandoz") is recalling three (3) lots of Transderm Scop® (Scopolamine) TDS, 1.5mg, 4 Count (Patches).
 
1/31/2017
Actavis recalls 12 lots of GLIPIZIDE 2.5 MG ER Tablets
 
NFI Consumer Products is in the process of working in cooperation with the Consumer Product Safety Commission ("CPSC") for the voluntary recall of our Lidocare 4% Lidocaine Pain Relief Patch Arm, Neck & Leg
 
1/26/2017
Invacare recall update on bariatric bed due to a field corrective action involving the junction box
 
1/20/2017
Vista Pharm recalls multiple products that may have been contaminated with the bacteria, Burkholderia cepacia
 
1/20/2017
Leo Pharma is conducting a field correction on Taclonex® Topical Suspension.
 
1/13/2017
 
1/5/2017
Invacare recalls bariatric bed due to a field corrective action involving the junction box
 
1/4/2017
BD Product Advisory for the BD Eclipse Needle
 
12/29/2016
Perrigo is voluntarily recalling lots of NDC 45802-736-84 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45g (Generic Duac) currently in the marketplace. 
 
12/22/2016
Teva Pharmaceuticals USA, Inc. is voluntarily recalling lots of AMOXICILLIN for Oral Suspension USP, 125mg/5mL distributed under the Teva Pharmaceuticals label
 
12/22/2016
FDA bans Powdered Surgeon Gloves.
 
12/20/2016
West Ward Columbus Inc. is initiating a market withdrawal of five lots of Prednisone Tablets USP, l mg.
 
12/9/2016
Supernus recalls lot of Trokendi XR 200 mg Caps.
 
12/8/2016
Novo Nordisk issues warning concerning stolen Victoza Pens. Click to read full notice.
 
12/2/2016
Teva recalls one lot of Risedronate Sodium Delayed Release Tablets 35 mg.
 
11/9/2016
Pfizer recalls one lot of Levoxyl 200 mcg tab.
 
10/27/2016
Teva recalls lots of Children's Qnasl 40 mcg and Qnasl80 mcg (beclomethasone dipropionate) Nasal Aeerosol.
 
10/27/2016
Akorn recalls one lot of Sodium Chloride Ophthalmic Solution.
 
10/26/2016
Dr. Reddy's Laboratories recalls one lot of  Olanzapine Tablets.
 
10/24/2016
Battle Creek recalls specific model numbers of  Thermophore Classic Moist Heat Pads.
 
10/5/2016
Par recalls lots of Travoprost Ophthalmic Solution USP 0.004%.
 
10/4/2016
Bausch + Lomb is recalling all lots of Peroxiclear 3%.
 
9/29/2016
Par recalls one multiple lots of Gildess, Gildess FE and Gildess 24 FE.
 
9/27/2016
Mericon recalls one lot of Monocal 100 tab.
9/26/2016
Teva recalls multiple lots of PARICALCITOL Capsules, 1, 2 and 4 mcg.
 
9/22/2016
Wockhardt USA/Morton Grove Pharmaceuticals recalls one lot of Ceftriaxone for Injection, USP 500 mg per Vial.
 
9/21/2016
BD recalls several BD catalogs of Luer-Lok Syringes, Luer-Lok Syringes with needles, and SafetyGlide Needle.
 
9/14/2016
Teva recalls MitoXantrone Inj USP.
 
9/13/2016
CORRECTED: Major/Rugby recalls multiple 4 oz lots of Major Label eye wash and Rugby Label eye wash.
 
9/12/2016
Novo Nordisk recalls batches of Glucagen Hypokit
 
9/7/2016
Shire recalls one lot of Vyvanse 30 mg caps
 
9/1/2016
Akorn recalls specific lots of Naphazolnie and various eye drop products
 
8/31/2016
Actavis recalls one lot of Ramipril Caps, USP 1.25 mg
 
8/31/2016
New! Dr. Reddy's recalls one lot of Zenatane 20 mg 30 caps.
 
 
8/23/2016
New! Impax recalls one lot of Lamotrigine orally disintigrating tablets 200 mg 30.
 
8/10/2016
New! PharmaTech LLC of Davie, FL is voluntarily recalling all liquid products from 10.20.2015 - 7.15.2016 
 
8/8/2016
New! Teva recalls one lot of Claravis
 
8/3/2016
 
8/1/2016
Teva recalls multiple lots of Amikacin Sulfate Inj USP.
 
7/20/2016
Pharma Tech recalls all lots of Diocto Liquid 50 mg/5ml.
 
7/20/2016
GSK recalls multiple lots of Bactroban cream and ointments.
 
7/13/2016
Catalent Pharma recalls one lot of Trokendi XR 50 mg Caps.
 
7/5/2016
Trividia initiates multiple lot recall of TRUEread, TRUEbalance, TRUEtrack & TRUEtest strips
Actavis recalls 5 lots of Glipizide
Allergan expands its May 2016 recall of Tazorac to include two more lots.
 
6/28/2016
Teva recalls one lot of Amoxicillin for Oral Suspension.
 
6/24/2016
Teva recalls one lot of Albuterol Syrup.
 
6/14/2016
Teva recalls all lots within expiry off Zecuity.
 
6/3/2016
Par recalls multple lots of Pramipexole Dihydrochloride Extended Release Tablets.
 
6/1/2016
Teva recalls one lot of mitoXANTRONE inj.
 
5/25/2016
Valeant recalls two lots of Lodrane.
 
5/23/2016
FSC Laboratories recalls one lot of Flexichamber Anti Static Valved Collapsible Holding Chamber
 
5/19/2016
Teva recalls one lot of Divalproex.
 
Virtus recalls one lot of VP CH PNV.
 
5/12/2016
Allergan recalls specific lots of Tazorac Gel 0.05%
 
5/2/2016
Pfizer recalls one lot of Zoloft 100 mg tab
 
4/28/2016
Teva recalls one lot of Linezolid Injection 600 mg/300 mL
 
4/7/2016
GSK recalls one lot of Breathe Right strips
 
4/4/2016
Akorn recalls Chlorhexidine Gluconate Oral Rinse 0.12% 16 oz bottle
 
3/24/2016
Invacare recalls Invacare Bariatric Beds and Invacare Bariatric Bed Foot Section specific models
 
3/21/2016
Actavis recalls lots of Ciprofloxacin Ophthalmic Solution (0.3% as base)
 
3/11/2016
Teva recalls one lot of Amikacin Sulfate Injection USP 1 gram/4 mL (250 mg/mL).
 
2/25/16
Independence Medical recalls multiple lots of TENA Ultra and TENA Ultraflush Washcloths.
 
2/22/16
Pfizer recalls one lot of Robitussin Peak cold cough+chest Congestion DM.
 
2/22/16
UPDATED and CORRECTED: Baxter Healthcare recalls one lot of 0.9% Sodium Chloride Irrigation.
 
2/10/2016 AstraZeneca recalls multiple lots of Tudorza 400 mcg pressair.
 
2/8/2016 Teva recalls one lot of Paricalcitol Cap 1 mcg 30 ct.
 
1/21/16
Bausch & Lomb recalls all distributed lots of Cyclopentolate Hydrochloride Ophthalmic Solution 1%, Tropicamide Ophthalmic Solution 1% and Tropicamide Ophthalmic Solution 0.5%.
 
1/20/16
Perrigo recalls one lot of Nystatin Powder 50,000,000 U oral 10.
 
1/14/16
Pfizer recalls lots of Lyrica 50 mg and 75 mg Cap 90 ct.
 
1/6/16
Mayne Pharma/Mylan recalls seven lots of Bromfenac Ophthalmic Solution 0.09%.