Class II · Moderate risk Completed
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
FDA Drug Recalls
358 recalls · Class II, newest first
Class II · Moderate risk Completed
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx…
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA…
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA…
Reason cGMP deviations
Class II · Moderate risk Completed
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk Completed
Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk Completed
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham…
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Completed
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE…
Reason Cross contamination: the excipient was found to be contaminated with theophylline.
Class II · Moderate risk Completed
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y…
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained…
Class II · Moderate risk Completed
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource…
Reason cGMP deviations
Class II · Moderate risk Completed
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL…
Reason cGMP deviations
Class II · Moderate risk Completed
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto…
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
Reason CGMP Deviations: Presence of NDMA impurity detected in product.