Recalls / Class II
Class IID-1288-2020
Product
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
- 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 #: a) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020
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.
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, N/A, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 16,443 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-05-22
- FDA classified
- 2020-06-04
- Posted by FDA
- 2020-06-10
- Terminated
- 2022-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1288-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.