Why it was recalled
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Product description
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Lot numbers, UPCs & expiration codes
Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
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-803-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 18, 2013
- FDA report date
- Jul 24, 2013
- Quantity
- 109,080 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-803-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65516
- Address
- 650 Cathill Rd
- Code information
- Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
- Postal code
- 18960-1512
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-803-2013
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 109,080 Bottles
- Termination date
- Dec 24, 2013
- Reason for recall
- Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2013