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

D-1280-2015 Class II Terminated

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

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