Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (
Summary
The FDA issued a Class I for Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 co by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals. Reason: Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets.
Details
Source
Drug Recall
External ID
D-0092-2022
Action Date
2021-11-10
Status
Completed
Category
drug
Product Description
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
Lot/Code Info: Lot #: 163935, Exp: 10/31/2022
Quantity Affected: a) 124, b) 29, c) 73
Reason for Recall
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-12
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 79 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals have FDA actions?
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0092-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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