McKesson Recalls Aspirin Chewable Tablets Due to Foreign Material
McKesson Packaging Services is recalling 6,717 cartons of 81 mg Aspirin Chewable Tablets because foreign material was found in the bulk inventory.
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 rubric, an FDA Class II recall with potential for adverse health consequences (foreign material in medication) corresponds to a severity score of 4 (Severe), as it is not Class I (Critical) but involves a significant risk of harm.
Plain-English summary
McKesson Packaging Services is recalling 6,717 cartons of Aspirin Chewable Tablets, 81 mg (NDC 63739-434-01). The product is packaged in 750-tablet cartons (25 x 30 blisters) and was distributed nationwide in the USA. The recall involves specific lot numbers: 0113784, 0113786, 0113834, and 0113887, all with an expiration date of 07/18.
The recall was initiated due to the presence of a foreign substance, specifically foreign material found in the bulk inventory. 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, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased these specific lot numbers should stop using the product and contact McKesson Packaging Services or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Aspirin
- Hazard
- Affected units
- 6,717
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 (5)
- Lot numbers: 0113784
- 0113786
- 0113834
- 0113887
- Exp. 07/18
Distribution
Distributed nationwide across the United States.
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