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.
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Prescription Drugs
💊 Drugs • 12,141 recalls
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
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Fresenius Kabi USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for impurities.