FDAFDA · Food and drugs·Recall number D-239-2013
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
Published April 10, 2013 · Recall initiated: February 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr Reddys Laboratories Tennessee LLC
- Distributor
- Nationwide
- Lot
- Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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