Recalls / Class II
Class IID-1582-2019
Product
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), 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
- Lot 172569, Exp 7/31/2019
Why it was recalled
Failed Dissolution Specifications: Out of specification result for the dissolution test.
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
- 6,579 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-01
- FDA classified
- 2019-07-31
- Posted by FDA
- 2019-08-07
- Terminated
- 2020-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1582-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.