Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
National Drug Code
Is NDC 54092-0189-81 recalled?
Pentasa · 240 CAPSULE in 1 BOTTLE (54092-189-81)
Yes — this exact package was recalled
2 FDA recalls name the code 54092-0189-81 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 250 mg/1
- Form
- Capsule · Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Type
- Human Prescription Drug
- Product code
- 54092-0189
Recalls naming this package
Class II · Moderate risk
MESALAMINE CR Capsule
Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.
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
- 54092-0606 See recall 2
- 54092-0191 Pentasa 1
- 54092-0252 Fosrenol 1
- 54092-0552 See recall 1
- 54092-0553 See recall 1
- 54092-0554 See recall 1
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