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
Reported: September 26, 2018 Initiated: August 23, 2018 #D-1214-2018
Product Description
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
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.
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 4716 bottle
- Distribution
- U.S.A. Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LUPIN SOMERSET. Units affected: 4716 bottle.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 26, 2018. Severity: Low. Recall number: D-1214-2018.
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