Shire Recalls Pentasa Capsules Due to Presence of Foreign 500 mg Tablets
Shire PLC is recalling 4,520 bottles of Pentasa (mesalamine) 250 mg capsules because 500 mg capsules were found in the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, fitting the Moderate severity criteria for minor labeling or packaging errors.
Plain-English summary
Shire PLC is recalling 4,520 bottles of Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count. The recall is due to the presence of foreign 500 mg capsules in bottles labeled to contain 250 mg capsules.
The affected product is identified by Lot Number AE7363A with an expiration date of 06/30/2019. The product was distributed nationwide and in Puerto Rico.
Consumers should check their medication for this specific lot number and expiration date. If found, they should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- PENTASA (MESALAMINE)
- Brand
- PENTASA
- Manufacturer
- Shire PLC
- Category
- Drug — Prescription Medication
- Affected units
- 4,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number AE7363A
- exp 06/30/2019
UPCs (2)
- 0354092191123
- 0354092189816
Distribution
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