Boehringer Ingelheim Recalls Dipyridamole Tablets Due to Foreign Tablet Presence
Boehringer Ingelheim is recalling 6,400 bottles of 75 mg Dipyridamole tablets because 50 mg Persantine 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 error where a different dose of the same drug (Persantine/Dipyridamole) was found in the bottle. This poses a risk of incorrect dosing, which is a significant safety hazard, but no injuries or illnesses are reported in the source text.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 6,400 bottles of DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottles. The recall is due to the presence of foreign tablets, specifically 50 mg Persantine tablets, which were found in the 75 mg bottles.
The affected product is distributed nationwide. The specific lot number is 554820 with an expiration date of 5/17. The product is distributed by Roxane Laboratories, Inc., Columbus, Ohio.
Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the description. They should contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 6,400
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 #: 554820
- 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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