Class III · Low risk
Oseltamivir Phosphate for Oral Suspension
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class I · High risk
Benzonatate capsules
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Benzphetamine tablets
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Testosterone Cypionate Injection
Incorrect Labeling: Incorrect lot number on secondary packaging
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk
Mephyton (phytonadione)
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Sulfur Ointment 10%
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Chlorhexidine Gluconate Oral Rinse USP 0.12%
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class II · Moderate risk
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Labeling: Missing instructions for use insert
Class II · Moderate risk
Paroex (Chlorhexidine Gluconate)
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Class III · Low risk
Epinephrine/Lidocaine HCl
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
NDC 64380-721-06 Tacrolimus Capsules
Failed Moisture Limits
Class II · Moderate risk
Zerbaxa (ceftolozane and tazobactam)
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Class III · Low risk
Benzhydrocodone and Acetaminophen Tablets
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A