Drug product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
D-1280-2015
Product summary
- Event
- Event 71684
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 96,640 bottles; b) 17,808 bottles
- Official record key
drug-enforcement:D-1280-2015
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 #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17
Distribution pattern: Nartionwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations