Status
Terminated
Drug Enforcement D-239-2013
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.
Classification
Class II
Report Date
April 10, 2013
Termination Date
October 1, 2013
Product Information
- 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
- Product quantity
- 4236 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Dr Reddys Laboratories Tennessee LLC
- Address
-
201 Industrial Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-239-2013
- Event ID
- 64405
- Recall initiation date
- February 15, 2013
- Center classification date
- April 2, 2013
- Code info
- Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
- More code info
- —