Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-239-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 4236 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr Reddys Laboratories Tennessee LLC
Original FDA data
Every field from FDA enforcement report D-239-2013, exactly as published.
Show all FDA fields
- City
- Bristol
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 64405
- Address
- 201 Industrial Dr
- Code information
- Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
- Postal code
- 37620-5413
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-239-2013
- Classification
- Class II
- Recalling firm
- Dr Reddys Laboratories Tennessee LLC
- Product quantity
- 4236 Bottles
- Termination date
- Oct 1, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2013