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.
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 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label."
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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