Recalls / Class III
Class IIID-0071-2022
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)
- Affected lot / code info
- Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep
Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 1,367,525 tablets
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2021-10-13
- FDA classified
- 2021-10-26
- Posted by FDA
- 2021-11-03
- Terminated
- 2022-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0071-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.