FDAClass IIApril 10, 2013

Amoxicillin for Oral Suspension recall: Sterility Concern

Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only…

Why was Amoxicillin for Oral Suspension recalled?

Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

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 #s: a) T200112; b) T200103, T200113; c) T200104, T200114

Product
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only…
Recalling firm
Dr Reddys Laboratories Tennessee LLC
Quantity
4236 Bottles
Distribution
Nationwide
Recall date
April 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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