FDAClass IIFebruary 1, 2017

Amoxicillin for Oral Suspension USP recall

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

Why was Amoxicillin for Oral Suspension USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Teva Pharmaceuticals USA
Quantity
133,601 bottles
Distribution
United States and Puerto Rico
Recall date
February 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls