Could cause temporary or reversible harm; serious harm is unlikely.
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.
| Distributed by / for | Dr Reddys Laboratories Tennessee LLC |
| NDC | 43598-222-80 |
| Full product label | 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 |
| Recalling firm | Dr Reddys Laboratories Tennessee LLC |
| Distribution | Nationwide |
| Quantity | 4236 Bottles |
| Recall initiated | 2013-02-15 |
| Report date | 2013-04-10 |
| Recall completed | 2013-10-01 |
| Recall number | D-239-2013 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Bristol TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗