FDA Recalls Acetaminophen in Health Kits Due to Labeling Error
A-S Medication Solutions is recalling Health Essentials Kits containing Acetaminophen 500mg tablets. The bottles were incorrectly labeled with prescription drug labels instead of OTC labels.
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 I, but the hazard is a labeling mix-up (prescription vs. OTC label) without reported injuries or deaths. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported harm typically fall under Moderate (2), as the risk is theoretical and administrative rather than a direct physical hazard like contamination or structural defect.
Plain-English summary
A-S Medication Solutions LLC is recalling 201,600 Health Essentials Kits distributed nationwide in the United States. The kits contain a bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100-count tablets. The recall is due to a labeling error where the Acetaminophen bottles were labeled with prescription drug labels instead of the correct over-the-counter (OTC) drug labels.
The affected product is manufactured by Major Pharmaceuticals and packaged exclusively by A-S Medication Solutions. The kits also include a hand sanitizer, a reusable face mask, cough drops, a digital thermometer, and disposable gloves. Specific lot numbers and expiration dates are listed in the recall notice.
Consumers who have purchased these Health Essentials Kits should stop using the Acetaminophen tablets and contact the recalling firm for instructions on how to return the product or obtain a refund. The FDA advises consumers to check their kits for the specific lot numbers and expiration dates listed in the official recall notice.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- A-S Medication Solutions LLC.
- Category
- Drug — OTC Medication
- Hazard
- Affected units
- 201,600
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 (20)
- Lots 323206
- 323207
- 323208
- 335353
- 335354
- 335355
- 335356
- 335358
- 335359
- 335360
- 335361
- 335362
- 335395
- 352116
- Expiry 7/31/2022
- 323209
- 323210
- 323211
- 323212
- 323213
Distribution
Distributed nationwide across the United States.
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