Class I - Dangerous
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
A-S Medication Solutions
Class I - Dangerous
Labeling: Not elsewhere classified - count on the label was incorrect.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Mckesson Packaging Services
Class I - Dangerous
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class I - Dangerous
Failed Content Uniformity Specifications
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Impax Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Impax Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class I - Dangerous
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class I - Dangerous
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
Impax Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class I - Dangerous
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class I - Dangerous
Subpotent Drug
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Amerisource Health Services
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Amerisource Health Services
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Impax Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp. Date