Home / Recalls / Mutual Pharmaceutical Company, Inc. / D-1280-2015

D-1280-2015 Class II Terminated

Recalled by Mutual Pharmaceutical Company, Inc. — Philadelphia, PA

FDA drug recall D-1280-2015 was initiated by Mutual Pharmaceutical Company, Inc. on July 9, 2015 and is designated Class II. Reason for recall: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer The recall status is terminated (terminated October 13, 2016). Affected quantity: a) 96,640 bottles; b) 17,808 bottles.

Recall Details

Product Type
Drugs
Report Date
August 5, 2015
Initiation Date
July 9, 2015
Termination Date
October 13, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 96,640 bottles; b) 17,808 bottles

Product Description

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

Reason for Recall

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Distribution Pattern

Nartionwide

Code Information

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

Other recalls by Mutual Pharmaceutical Company, Inc.

  • D-0572-2016 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 1 (October 9, 2015)
  • D-1421-2015 Class III — Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual (July 16, 2015)
  • D-1425-2015 Class III — Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (July 16, 2015)
  • D-1423-2015 Class III — Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual P (July 16, 2015)
  • D-1420-2015 Class III — Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual (July 16, 2015)
  • D-1424-2015 Class III — Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (July 16, 2015)
  • D-1422-2015 Class III — Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual P (July 16, 2015)
  • D-1281-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5348 (July 9, 2015)
  • D-1282-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, M (July 9, 2015)
  • D-0414-2015 Class II — Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MU (March 10, 2015)

FDA data resources