Why it was recalled
Failed Dissolution Specifications
Product description
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
Lot numbers, UPCs & expiration codes
Lot: 71545AA, exp 7/2019
Where it was sold
Nationwide 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-1026-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 30, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 3,161 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MAJOR PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-1026-2018, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80659
- Address
- 17177 N Laurel Park Dr
- Code information
- Lot: 71545AA, exp 7/2019
- Postal code
- 48152-2693
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1026-2018
- Classification
- Class II
- Recalling firm
- MAJOR PHARMACEUTICALS
- Product quantity
- 3,161 Cartons
- Termination date
- Dec 2, 2019
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jul 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2018