Class III · Low risk Terminated
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only…
Reason Failed Dissolution Specifications
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For…
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk Terminated
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk Terminated
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar…
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class III · Low risk Terminated
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per…
Reason Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279…
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream…
Class III · Low risk Terminated
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc…
Reason Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class III · Low risk Terminated
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West…
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III · Low risk Terminated
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health…
Reason Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18…
Class III · Low risk Terminated
ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a…
Reason Labeling: Missing label; potential for missing primary container label on the vial.
Class III · Low risk Terminated
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton…
Reason Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol…
Class III · Low risk Terminated
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850…
Reason Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class III · Low risk Terminated
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca…
Reason Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class III · Low risk Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC…
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b)…
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1…
Reason Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May…
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by…
Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class III · Low risk Terminated
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC#…
Reason Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class III · Low risk Terminated
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason Presence of precipitate
Class III · Low risk Terminated
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for…
Reason Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class III · Low risk Terminated
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore…
Reason Defective Container: Repetitive complaints received indicating pump not working.
Class III · Low risk Terminated
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only…
Reason Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class III · Low risk Terminated
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by…
Reason Container packaging defect.
Class III · Low risk Terminated
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured…
Reason Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL…
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.