FDA Recall D-0009-2019

Endo Pharmaceuticals, Inc. · Malvern, PA

Class I — life-threatening Terminated 505 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.

Lot / code: Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21

Quantity: 2,856 bottles

Reason for recall

Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."

Recall record

Recall number: D-0009-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2018-09-17
Classified by FDA Center: 2018-10-09
FDA published: 2018-10-10
Terminated: 2020-02-04
Recalling firm: Endo Pharmaceuticals, Inc.
Firm location: Malvern, PA

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