Vica-Cet Back Pain Relief tablets recalled for stability specification failure
Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as Class III. The recall is based on failed stability specifications with no reported illnesses, injuries, or harm. The hazard is documented but theoretical, supporting a Low severity classification.
Plain-English summary
Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets (Acetaminophen 250 mg / Aspirin 250 mg / Caffeine 65 mg) nationwide in the USA. The affected product consists of approximately 1,367,525 tablets packaged in 2-tablet packets as part of PO# 8967 for Tellus / The Provision First Aid Line.
The recall was initiated because stability testing revealed out-of-specification results for Salicylic Acid, an aspirin-related compound, in certain lots. The affected lots include: Lot #AK-9455 (expiration 22-Jan), Lot #AK-1109 (expiration 23-Mar), Lot #AK-1110 (expiration 23-Mar), and Lot #K-9821 (expiration 22-Sep).
Consumers who have purchased this product should stop using it. Consumers with questions or concerns should contact Ultra Seal Corporation or consult their healthcare provider.
The recalled product
- Product
- Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Pain Relief Tablets
- Affected units
- 1,367,525
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 (7)
- Lot #: AK-9455
- exp. date 22-Jan
- AK-1109
- AK-1110
- exp. date 23-Mar
- K-9821
- exp. date 22-Sep
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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