Drug product
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.
D-1032-2020
Product summary
- Event
- Event 85230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 624 bottles
- Official record key
drug-enforcement:D-1032-2020
Official wording
Reason: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Code information: Lot #: AA39490, Exp 03/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations