FDA Recall D-0092-2022
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · Burbank, CA
Class I — life-threatening Completed 1675 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
Reason for recall
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Recall record
- Recall number
D-0092-2022- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2021-10-12
- Classified by FDA Center
- 2021-11-02
- FDA published
- 2021-11-10
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Firm location
- Burbank, CA