Why it was recalled
Failed Dissolution Specifications:
Product description
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
Lot numbers, UPCs & expiration codes
Lot# 71545A, Expiry date: 07/19
Where it was sold
Nationwide in the USA.
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-1025-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 29048 500-count bottles (14,524,000 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1025-2018, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 80364
- Address
- 1809 Wilson Rd
- Code information
- Lot# 71545A, Expiry date: 07/19
- Postal code
- 43228-9579
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1025-2018
- Classification
- Class II
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 29048 500-count bottles (14,524,000 tablets)
- Termination date
- Apr 29, 2020
- Reason for recall
- Failed Dissolution Specifications:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jul 24, 2018
- Center classification date
- Aug 2, 2018