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
Product summary
- 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
Microbial Contamination