FDA Drug recall D-1245-2019
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class III recall of Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc by Lupin Somerset, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1245-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-10 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Somerset |
| Distribution | US |
Product
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 43386-540-01 |
|---|---|
| ndc | 43386-540-05 |
| ndc | 43386-541-01 |
| ndc | 43386-541-05 |
| ndc | 43386-542-01 |
| ndc | 43386-542-05 |
| ndc | 43386-543-01 |
| ndc | 43386-543-05 |
| ndc | 43386-544-01 |
| ndc | 43386-544-05 |
| code_info | Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1245-2019%22
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