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Recall Observatory FDA recall evidence

Drug 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, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807

D-239-2013

February 15, 2013

Class II

Product summary

Firm
Dr Reddys Laboratories Tennessee LLC
Event
Event 64405
Status
Terminated
Classification
Class II
Quantity
4236 Bottles
Official record key
drug-enforcement:D-239-2013

Official wording

Reason: 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.

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

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination