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Recall Observatory FDA recall evidence

Drug product

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01

D-1247-2019

April 10, 2019

Class III

Product summary

Firm
LUPIN SOMERSET
Event
Event 82581
Status
Terminated
Classification
Class III
Quantity
324 bottles
Official record key
drug-enforcement:D-1247-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications