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

FDA recall notice · announced February 1, 2017 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: United States and Puerto Rico
Lot/code information: Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Quantity: 133,601 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0440-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.