Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc
Summary
The FDA issued a Class I for Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx onl by Bryant Ranch Prepack, Inc.. Reason: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets an.
Details
Source
Drug Recall
External ID
D-1188-2022
Action Date
2022-07-20
Status
Terminated
Category
drug
Product Description
Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
Lot/Code Info: Lot #: 179643, Exp. Date 08/31/2023.
Reason for Recall
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Distribution
Distributed to one wholesaler in AL for further distribution in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-17
Company
Burbank, CA
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 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 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.) 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. have FDA actions?
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1188-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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