Why it was recalled
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Product description
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Lot numbers, UPCs & expiration codes
Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
Where it was sold
USA 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-1274-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2020
- FDA report date
- Jun 3, 2020
- Quantity
- 68,376 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1274-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 85555
- Address
- 1809 Wilson Rd
- Code information
- Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
- Postal code
- 43228-9579
- Report date
- Jun 3, 2020
- Product type
- Drugs
- Recall number
- D-1274-2020
- Classification
- Class II
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 68,376 bottles
- Termination date
- Mar 25, 2023
- Reason for recall
- Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 13, 2020
- Initial firm notification
- Letter
- Center classification date
- May 26, 2020