Recalls / Class II
Class IID-1274-2020
Product
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.
- Brand name
- Doxycycline Hyclate
- Generic name
- Doxycycline Hyclate
- Active ingredient
- Doxycycline Hyclate
- Route
- Oral
- NDC
- 0143-2112
- FDA application
- ANDA065095
- Affected lot / code info
- Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
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
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 68,376 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-05-13
- FDA classified
- 2020-05-26
- Posted by FDA
- 2020-06-03
- Terminated
- 2023-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1274-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.