Recalls / Class II
Class IID-1026-2018
Product
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
- Brand name
- Doxycycline Hyclate
- Generic name
- Doxycycline Hyclate
- Active ingredient
- Doxycycline Hyclate
- Route
- Oral
- NDC
- 0904-0430
- FDA application
- ANDA065095
- Affected lot / code info
- Lot: 71545AA, exp 7/2019
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- MAJOR PHARMACEUTICALS
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr, N/A, Livonia, Michigan 48152-2693
Distribution
- Quantity
- 3,161 Cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-07-30
- FDA classified
- 2018-08-02
- Posted by FDA
- 2018-08-08
- Terminated
- 2019-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1026-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.