Home / Recalls / Mutual Pharmaceutical Company, Inc. / D-0414-2015

D-0414-2015 Class II Terminated

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

FDA drug recall D-0414-2015 was initiated by Mutual Pharmaceutical Company, Inc. on March 10, 2015 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: during long-term stability testing. The recall status is terminated (terminated July 15, 2016). Affected quantity: 23246 bottles.

Recall Details

Product Type
Drugs
Report Date
March 25, 2015
Initiation Date
March 10, 2015
Termination Date
July 15, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23246 bottles

Product Description

Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01

Reason for Recall

Failed Impurities/Degradation Specifications: during long-term stability testing.

Distribution Pattern

Nationwide

Code Information

Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.

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-1425-2015 Class III — Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (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-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-1422-2015 Class III — Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual P (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-1280-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5348 (July 9, 2015)

FDA data resources