Persantine Tablets Recalled Due to Presence of Foreign 50 mg Tablets
Boehringer Ingelheim is recalling 2,562 bottles of 75 mg Persantine tablets because 50 mg tablets were found inside the bottles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medication dosage error (50 mg tablets in 75 mg bottles), which poses a risk of harm due to incorrect dosing, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 2,562 bottles of Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles. The recall is due to the presence of foreign tablets, specifically 50 mg Persantine tablets, which were found in 75 mg Persantine 100-count bottles.
The affected product is identified by Lot #456520 and an expiration date of 5/17. The product is distributed nationwide. This is a prescription-only medication.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,562
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 #:456520
- Exp. 5/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boehringer Ingelheim Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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