Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
National Drug Code
Is NDC 43386-0541-01 recalled?
Morphine Sulfate · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-541-01)
Yes — this exact package was recalled
2 FDA recalls name the code 43386-0541-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Morphine Sulfate
- Strength
- MORPHINE SULFATE 30 mg/1
- Form
- Tablet, Film Coated, Extended Release · Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Type
- Human Prescription Drug · DEA CII
- Product code
- 43386-0541
Recalls naming this package
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 43386-0069 Fluocinolone Acetonide 3
- 43386-0060 GaviLyte - C TM 2
- 43386-0450 Nitrofurantoin 2
- 43386-0038 Voriconazole 1
- 43386-0050 Gavilyte-N 1
- 43386-0118 Hydrocodone Bitartrate and Homatropine Methylbromide 1
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