Drug product
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.
D-1033-2020
Product summary
- Event
- Event 85230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172,320 bottles
- Official record key
drug-enforcement:D-1033-2020
Official wording
Reason: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Code information: Lot #: 3983720, Exp 10/2020; 3990461, 3990464, 3990465, 3990466, 3990470, Exp 11/2020; AA42499, AA42510, AA44468, AA44470, Exp 04/2021; AA55073, AA55074, AA55075, Exp 05/2021; AA61486, Exp 06/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations