Recalls / Class II
Class IID-1293-2020
Product
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
- Brand name
- Doxycycline
- Generic name
- Doxycycline Hyclate
- Active ingredient
- Doxycycline Hyclate
- Route
- Oral
- NDC
- 62584-693
- FDA application
- ANDA065095
- Affected lot / code info
- Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021
Why it was recalled
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 15,755 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-05-19
- FDA classified
- 2020-06-08
- Posted by FDA
- 2020-06-17
- Terminated
- 2022-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1293-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.