Mutual Pharmaceutical Company, Inc.: Chemical Contamination; benzophenone leached from the product label varnish

Agency Publication Date: September 9, 2015

Affected Products

Product: Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01

lot #s: 6669101 & 6669201, exp 12/15 and 6708201 & 6708301, exp 8/16

Product: Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

lot #s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16

Product: Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01

lot #s: 6667301 & 6667401, exp 11/15 and 6699201, exp 6/16

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

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

Product: Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01

lot #s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17

Product: Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01

lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71836

Status: Resolved

Manufacturer: Mutual Pharmaceutical Company, Inc.

Manufactured In: United States

Units Affected: 6 products (25,272 bottles; 97,859 bottles; 63,975 bottles; 5472 bottles; 14,112 bottles; 10,080 bottles)

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Sources: FDA iRES · Raw API Response

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