Drug recall D-1246-2019

Class III Terminated reported May 1, 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

Lots and codes

Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.

Recall details

Recalling firm
LUPIN SOMERSET, Somerset, NJ
Quantity
3,444 bottles
Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
April 10, 2019
Terminated
October 14, 2022

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