Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC…
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Defective Container
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
Reason Discoloration
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