Drug recall D-1244-2019

Class III Terminated reported May 1, 2019

Product

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.

Recall details

Recalling firm
LUPIN SOMERSET, Somerset, NJ
Quantity
15,320 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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