Recalls / Class I
Class ID-1187-2022
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
Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.
- Affected lot / code info
- Lot #: 179642, Exp. Date 11/30/2023.
Why it was recalled
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.
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, Burbank, California 91504-3425
Distribution
- Distribution pattern
- Distributed to one wholesaler in AL for further distribution in the US.
Timeline
- Recall initiated
- 2022-06-17
- FDA classified
- 2022-07-08
- Posted by FDA
- 2022-07-20
- Terminated
- 2024-04-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1187-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.