Class II · Moderate risk
Ambi 3brm/15dm/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Ambi 2cpm/15dm/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25cpd/200gfn
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/120gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/100gfn/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25dph/7.5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 20dm100gfn10peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 15dm/100gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Lansoprazole Delayed-release Capsules
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class II · Moderate risk
Terazosin Hydrochloride Capsules
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class II · Moderate risk
Medi-bolic Booster Injectable
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Class II · Moderate risk
Furosemide Injection USP
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class II · Moderate risk
Hillyard
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Class II · Moderate risk
12-Hour Sinus
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class II · Moderate risk
Taztia XT
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class II · Moderate risk
Prednisone tablets
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Class II · Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class II · Moderate risk
Propylthiouracil Tablets
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.