Recalls / Class II

Class IID-0440-2017

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

Affected lot / code info

Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19

Why it was recalled

Subpotency: due to a low, out of specification test result for assay during stability testing.

Recalling firm

Firm

Teva Pharmaceuticals USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505

Distribution

Quantity

133,601 bottles

Distribution pattern

United States and Puerto Rico

Timeline

Recall initiated

2016-12-21

FDA classified

2017-01-24

Posted by FDA

2017-02-01

Terminated

2018-02-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0440-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.