August 2018 FDA Recall Morphine Sulfate by Lupin Somerset
D-1214-2018 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Lupin Somerset on August 23, 2018 for the product Morphine Sulfate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1214-2018

Reason for Recall
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Initiated
08-23-2018
Reported
09-26-2018
Quantity
4716 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80874
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

Batch or Lot Expiration Information

Lot# S800232, Exp 2/20

Affected Packages Involved in this Recall

43386-540-01 Morphine Sulfate
43386-540-05 Morphine Sulfate
43386-541-01 Morphine Sulfate
43386-541-05 Morphine Sulfate
43386-542-01 Morphine Sulfate
43386-542-05 Morphine Sulfate
43386-543-01 Morphine Sulfate
43386-543-05 Morphine Sulfate
43386-544-01 Morphine Sulfate
43386-544-05 Morphine Sulfate