FDA Recall D-1188-2022

Bryant Ranch Prepack, Inc. · Burbank, CA

Class I — life-threatening Terminated 655 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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: 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.

Recall record

Recall number: D-1188-2022
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed to one wholesaler in AL for further distribution in the US.
Recall initiated: 2022-06-17
Classified by FDA Center: 2022-07-08
FDA published: 2022-07-20
Terminated: 2024-04-02
Recalling firm: Bryant Ranch Prepack, Inc.
Firm location: Burbank, CA

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