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
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, 0.1 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
- Brand
- Mutual Pharmaceutical Company, Inc.
- UPC
- 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
Units Affected
a) 96,640 bottles; b) 17,808 bottles