Recalls / Class I
Class ID-0009-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21
Why it was 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."
Recalling firm
- Firm
- Endo Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 Atwater Dr, Malvern, Pennsylvania 19355-8701
Distribution
- Quantity
- 2,856 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-09-17
- FDA classified
- 2018-10-09
- Posted by FDA
- 2018-10-10
- Terminated
- 2020-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.