Rugby Enteric Coated Aspirin 81 mg Recalled for Labeling Error
Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg due to a label mix-up where one bottle contained Acetaminophen 500 mg.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg, 120-count tablets, distributed by Rugby Laboratories, Inc. The recall is due to a labeling error where a pharmacist reported that one bottle labeled as Enteric Coated Aspirin 81 mg actually contained Acetaminophen 500 mg tablets.
The affected product is identified by Lot # 13A026 and an expiration date of 01/15. The product was distributed nationwide. The NDC is 0536-3086-41 and the UPC is 3 0536-3086-41 9.
Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
- Manufacturer
- Advance Pharmaceutical Inc
- Hazard
- Affected units
- 16,440
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 #: 13A026
- Exp 01/15
Distribution
Distributed nationwide across the United States.
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