Home / Recalls / Mutual Pharmaceutical Company, Inc. / D-1423-2015

D-1423-2015 Class III Terminated

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

FDA drug recall D-1423-2015 was initiated by Mutual Pharmaceutical Company, Inc. on July 16, 2015 and is designated Class III. Reason for recall: Chemical Contamination; benzophenone leached from the product label varnish The recall status is terminated (terminated October 13, 2016). Affected quantity: 5472 bottles.

Recall Details

Product Type
Drugs
Report Date
September 16, 2015
Initiation Date
July 16, 2015
Termination Date
October 13, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5472 bottles

Product Description

Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01

Reason for Recall

Chemical Contamination; benzophenone leached from the product label varnish

Distribution Pattern

Nationwide

Code Information

lot #s 6671801, exp 12/16 and 6706401, exp 7/17

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-1424-2015 Class III — Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (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-1280-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.1 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-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)

FDA data resources