Drug product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
D-1282-2015
Product summary
- Event
- Event 71684
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,892 bottles
- Official record key
drug-enforcement:D-1282-2015
Official wording
Reason: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Code information: Lot #: 6676701 and 6676801, exp 1/17
Distribution pattern: Nartionwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations