D-0009-2019 Class I Terminated
FDA drug recall D-0009-2019 was initiated by Endo Pharmaceuticals, Inc. on September 17, 2018 and is designated Class I. 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 ti… The recall status is terminated (terminated February 4, 2020). Affected quantity: 2,856 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 10, 2018
- Initiation Date
- September 17, 2018
- Termination Date
- February 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,856 bottles
Product Description
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.
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."
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21