FDA recall D-239-2013

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-02-15

Report date

2013-04-10

Termination date

2013-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bristol, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-239-2013