Product Detail

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

Recall Number D-239-2013

Classification Class II

Code Info Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114

Product Distributed Qty 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.

Event Detail

Event Id 64405

Product Type Drugs

Status Ongoing

Recalling Firm Dr Reddys Laboratories Tennessee, Bristol, TN, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-02-15

Initial Firm Notification of Consignee or Public
Letter

Distribution Pattern Nationwide