Class II · Moderate risk
Metoprolol Tartrate Tablets USP 100 mg
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
FDA Drug Recalls
621 recalls · Class II, newest first
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Class II · Moderate risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class II · Moderate risk
Clopidogrel Tablets
Presence of foreign matter
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk
Sterile Water for Inj.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
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 II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Presence of particulate matter in solution - black and transparent particles
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk
Hand Sanitizer
Discoloration and Presence of Foreign Substance
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk
Unasyn (ampicillin sodium/sulbacatam)
Presence of Particulate Matter: particulate matter identified after reconstitution.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Estradiol
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.