Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
National Drug Code
Is NDC 0591-2245-22 recalled?
Mesalamine · 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22)
Yes — this exact package was recalled
2 FDA recalls name the code 0591-2245-22 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
- Mesalamine
- Strength
- MESALAMINE 1.2 g/1
- Form
- Tablet, Delayed Release · Oral
- Labeler
- Actavis Pharma, Inc.
- Type
- Human Prescription Drug
- Product code
- 0591-2245
Recalls naming this package
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability 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
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