Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Reported: May 1, 2019 Initiated: April 10, 2019 #D-1243-2019
Product Description
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 17,328 bottles
- Distribution
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01. Recalled by LUPIN SOMERSET. Units affected: 17,328 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2019. Severity: Low. Recall number: D-1243-2019.
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