FDA-Drug2021-11-03Class III

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)

Ultra Seal Corporation
Hazard

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Sold states
Nationwide in the USA.
Affected count
1,367,525 tablets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0071-2022

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