FDA recall D-1187-2022

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.

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.

Key facts

Status

Terminated

Initiation date

2022-06-17

Report date

2022-07-20

Termination date

2024-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1187-2022