Why it was recalled
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Product description
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Lot numbers, UPCs & expiration codes
Lot #: AS1413A, AS1414A; Exp. 11/18
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-1515-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 18, 2016
- FDA report date
- Sep 28, 2016
- Quantity
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1515-2016, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75083
- Address
- 401 Industrial Way West
- Code information
- Lot #: AS1413A, AS1414A; Exp. 11/18
- Postal code
- 07724-2209
- Report date
- Sep 28, 2016
- Product type
- Drugs
- Recall number
- D-1515-2016
- Classification
- Class III
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Product quantity
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
- Termination date
- Sep 1, 2017
- Reason for recall
- Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 19, 2016