Drug 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.
D-0009-2019
Product summary
- Event
- Event 81034
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,856 bottles
- Official record key
drug-enforcement:D-0009-2019
Official wording
Reason: 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."
Code information: Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect