American Health Packaging Recalls Aspirin and Dipyridamole Capsules
American Health Packaging is recalling specific lots of Aspirin and Extended-release Dipyridamole Capsules due to an unknown impurity found in stability samples.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant quality failures like out-of-specification impurities.
Plain-English summary
American Health Packaging is recalling 13,229 cartons of Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg. The product is distributed nationwide in the United States. The recall involves specific lots with expiration dates ranging from March 31, 2019, to November 30, 2019.
The recall was initiated because stability samples failed impurities and degradation specifications, specifically showing an out-of-specification result for an unknown impurity. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. The affected NDC numbers are 60687-305-32 for cartons and 60687-305-33 for blister packs.
The recalled product
- Product
- Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,229
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 (11)
- Lot
- expiry: Lot 174262
- exp. 03/31/2019
- Lot 176469
- exp. 06/30/2019
- Lot 177897
- exp. 08/31/2019
- Lots 178318 and 178436
- exp. 09/30/2019
- Lot 179547 and 179656
- exp. 11/30/2019
Distribution
Distributed nationwide across the United States.
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