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.
Hazard
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
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Products
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.
- Brand
- Mutual Pharmaceutical Company, Inc.
- UPC
- Lot #: a) 6643901, exp 5/16, 6677201, exp 1/17; b) 6677101, EXP 1/17
Units Affected
a) 39,036 bottles and b) 2,082 bottles