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.
Reported: October 10, 2018 Initiated: September 17, 2018 #D-0009-2019
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."
Details
- Recalling Firm
- Endo Pharmaceuticals, Inc.
- Units Affected
- 2,856 bottles
- Distribution
- Nationwide in the USA.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Endo Pharmaceuticals, Inc.. Units affected: 2,856 bottles.
Why was this product recalled? ▼
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."
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2018. Severity: Critical. Recall number: D-0009-2019.
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