Recalls, Safety & Important Product Information
1. Epic Pharma has issued a voluntary, retail-level recall for Estradiol Tablets USP, 2 mg, lot# 18103A.
2. Dr. Reddy’s has issued a voluntary retail-level recall for Divalproex Sodium Extended-Release Tablets 250 mg.
3. Lupin Pharmaceuticals has issued a voluntary retail-level recall for several lots of Bimatoprost Ophthalmic Solution, 0.03%.
1. Sun Pharma has initiated a retail level recall for Bromfenac Ophthalmic Solution.
1. Ascend Labs has initiated a retail level recall as a precautionary measure for Quetiapine Tablets.
1. Pfizer is voluntarily recalling one lot of Levoxyl (levothyroxine sodium tablets, USP) tablets as the assay result at the six-month stability time point was out of specification. Pfizer completed a Health Hazard Assessment which concluded that the use of the impacted product has a low probability of being associated with adverse events and the potential risk to patients arising from this issue is considered to be low.
1. Takeda Pharmaceuticals USA, Inc. is conducting a recall, to the retail level, for Lubiprostone, Amitiza, 8 MCG Capsules.
1. Akorn is conducting a recall, to the retail level, for 10 lots of Clindamycin Pledgets due to an out-of-specification result obtained in one lot for an unknown impurity.
1.Orexigen Therapeutics, Inc. is conducting a voluntary recall of Contrave 8 mg/90 mg (naltrexone HCl/bupropion HCI) bottles, NDC 51267-890-99.
1.Pfizer Consumer Healthcare is voluntarily recalling several lots of ThermaCare Muscle Pain Therapy Heatwraps and ThermaCare Menstrual Pain Therapy Heatwraps due to a potential for leakage of the ingredients contained in the product.
1. GSK Recall of Prevacid 24HR Capsules (14, 28, and 42 ct)
1. Greenstore LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling one lot of Glipizide XL due to the potential presence of particulate matter.
2. Valeant has issued a voluntary recall, to the retail level, for all lots of Ocean Saline Nasal Spray manufactured by Product Quest.
1. Fresenius Kabi is voluntarily recalling several batches of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial.
1. Takeda Pharmaceuticals is voluntarily recalling several lots of Pioglitazone and Metformin Hydrochloride Extended Release Actoplus Met XR, 15 mg/1000 mg tablets.
1. Solco Valsartan and Valsartan HCTZ Recall Update. See link below for complete recall information.
this recall of the Covidien Product.
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.