Recalls / Class I
Class ID-0092-2022
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
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
- Affected lot / code info
- Lot #: 163935, Exp: 10/31/2022
Why it was recalled
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- a) 124, b) 29, c) 73
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-11-02
- Posted by FDA
- 2021-11-10
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.