Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count…
Reason Subpotent drug
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count…
Reason Subpotent drug
Class III · Low risk Terminated
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per…
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ…
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk Terminated
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green…
Reason Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk Terminated
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count…
Reason Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class III · Low risk Terminated
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured…
Reason Subpotent Drug: Flurandrenolide is subpotent.
Class III · Low risk Terminated
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per…
Reason Failed pH specification
Class III · Low risk Terminated
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case…
Reason Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA…
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada…
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC…
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC…
Reason Subpotent drug
Class III · Low risk Terminated
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons…
Reason Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound…
Class III · Low risk Terminated
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by…
Reason Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class III · Low risk Terminated
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg…
Reason Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room…
Class III · Low risk Terminated
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode…
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Class III · Low risk Terminated
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01)…
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Class III · Low risk Terminated
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC…
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Class III · Low risk Terminated
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription…
Reason Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class III · Low risk Terminated
AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E…
Reason Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Class III · Low risk Terminated
Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478…
Reason Subpotent Drug
Class III · Low risk Terminated
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC…
Reason Subpotent Drug
Class III · Low risk Terminated
Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals…
Reason Failed Impurities/Degradation Specifications