Drug product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
D-1281-2015
Product summary
- Event
- Event 71684
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 39,036 bottles and b) 2,082 bottles
- Official record key
drug-enforcement:D-1281-2015
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) 6643901, exp 5/16, 6677201, exp 1/17; b) 6677101, EXP 1/17
Distribution pattern: Nartionwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations