Class II ยท Moderate risk
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
National Drug Code
Is NDC 63304-0089-13 recalled?
Mesalamine · 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)
Yes — this exact package was recalled
1 FDA recall names the code 63304-0089-13 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.
1 of these recalls is still ongoing.
- Active ingredient
- Mesalamine
- Strength
- MESALAMINE 500 mg/1
- Form
- Capsule, Extended Release · Oral
- Labeler
- Sun Pharmaceutical Industries Inc.
- Type
- Human Prescription Drug
- Product code
- 63304-0089
Recalls naming this package
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
- 63304-0827 See recall 3
- 63304-0616 Doxycycline 2
- 63304-0829 Atorvastatin Calcium 2
- 63304-0175 Mesalamine 1
- 63304-0240 See recall 1
- 63304-0241 See recall 1
Free recall alerts
Know the day your medication is recalled
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