Why it was recalled
Superpotent drug: Out of specification test result for assay during stability testing.
Product description
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Lot numbers, UPCs & expiration codes
Lot # 35434158A, Exp 6/17
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-1470-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 24, 2016
- FDA report date
- Aug 31, 2016
- Quantity
- 53,328 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1470-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74540
- Address
- 425 Privet Rd
- Code information
- Lot # 35434158A, Exp 6/17
- Postal code
- 19044-1220
- Report date
- Aug 31, 2016
- Product type
- Drugs
- Recall number
- D-1470-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 53,328 bottles
- Termination date
- Feb 7, 2017
- Reason for recall
- Superpotent drug: Out of specification test result for assay during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 24, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2016