FDA Drug Class II — Moderate

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

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