D-239-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2013
- Initiation Date
- February 15, 2013
- Termination Date
- October 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4236 Bottles
Product Description
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 Pattern
Nationwide
Code Information
Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114