FDA Drug Recalls

17,898 recalls, newest first

Class III · Low risk Terminated Jan 29, 2018

Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging…

Reason Subpotent Drug: Out of specification for assay (stability testing)

Mckesson Packaging Services NDC 63739-549-51 D-0338-2018

Class I · High risk Terminated Jan 26, 2018

Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus…

Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…

Primus Pharmaceuticals, Inc. NDC 68040-606-16 D-0347-2018

Class I · High risk Terminated Jan 26, 2018

Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus…

Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…

Primus Pharmaceuticals, Inc. NDC 68040-605-16 D-0346-2018

Class I · High risk Terminated Jan 26, 2018

Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ…

Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…

Primus Pharmaceuticals, Inc. NDC 68040-602-16 D-0345-2018

Class I · High risk Terminated Jan 26, 2018

Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ…

Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…

Primus Pharmaceuticals, Inc. NDC 68040-601-16 D-0344-2018

Class II · Moderate risk Terminated Jan 25, 2018

PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 55289-673-24 D-0341-2018

Class III · Low risk Terminated Jan 24, 2018

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix…

Reason Superpotent drug: failed assay throughout the stick after 6 months stability.

Oxygen Development Llc D-0584-2018

Class III · Low risk Terminated Jan 24, 2018

Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office…

Reason Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.

JCB Laboratories LLC D-0246-2018

Class II · Moderate risk Terminated Jan 22, 2018

Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL…

Reason Labeling: Label Error on Declared Strength

Astellas Pharma US Inc NDC 0469-3211-10 D-0548-2018

Class III · Low risk Terminated Jan 22, 2018

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC…

Reason Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

AbbVie Inc. NDC 0074-4456-51 D-0412-2018

Class III · Low risk Terminated Jan 22, 2018

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc…

Reason Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Ascent Pharmaceuticals, Inc. NDC 31722-917-01 D-0248-2018