The Recall Desk
ModerateFDA (Drugs)·D-1483-2014·Announced 2014-08-06

McKesson Recalls Aspirin DR Tablets for Dissolution Failure

McKesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets because they failed to meet dissolution specifications at the 12-month time interval.

What this means for you

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 the product is not likely to cause adverse health consequences. The failure is a quality specification issue (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

McKesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets, USP 325 mg. The recall involves 1,511,250 tablets distributed nationwide under Lot 0093943.

The recall was initiated because the product failed to meet the required dissolution specification at the 12-month time interval. This means the tablets may not release the medication as intended over time.

Consumers with this specific lot of Aspirin DR should stop using the product and contact their pharmacist or McKesson Packaging Services for further instructions or a refund.

The recalled product

Product
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
Affected units
1,511,250

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 (1)

  • Lot 0093943

Distribution

Distributed nationwide across the United States.