The Recall Desk
LowFDA (Drugs)·D-0071-2022·Announced 2021-11-03

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.

What this means for you

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
Hazard
  • stability-failure
  • out-of-specification-aspirin-metabolite

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.