Recalls / Class II
Class IID-1024-2018
Product
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
- 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# 71545B, Expiry date: 01/19
Why it was recalled
Failed Dissolution Specifications:
Recalling firm
- Firm
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 29,048 bottles (1,452,400 tablets)
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-07-24
- FDA classified
- 2018-08-02
- Posted by FDA
- 2018-08-08
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1024-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.