FDA recall D-1246-2019

Product

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-04-10

Report date

2019-05-01

Termination date

2022-10-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1246-2019