Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manuf...
FDA Recall #D-0440-2017 — Class II — December 21, 2016
Product Description
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Reason for Recall
Subpotency: due to a low, out of specification test result for assay during stability testing.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
133,601 bottles
Distribution
United States and Puerto Rico
Code Information
Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated