Mutual Pharmaceutical Company, Inc.: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Agency Publication Date: July 30, 2015

Affected Products

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

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

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.

Lot #: a) 6643901, exp 5/16, 6677201, exp 1/17; b) 6677101, EXP 1/17

Product: Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

Lot #: 6676701 and 6676801, exp 1/17

Lot Numbers:

6676701

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71684

Status: Resolved

Manufacturer: Mutual Pharmaceutical Company, Inc.

Manufactured In: United States

Units Affected: 3 products (a) 96,640 bottles; b) 17,808 bottles; a) 39,036 bottles and b) 2,082 bottles; 20,892 bottles)

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Sources: FDA iRES · Raw API Response

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