Drug 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)
D-0071-2022
Product summary
- Event
- Event 88843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,367,525 tablets
- Official record key
drug-enforcement:D-0071-2022
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Code information: Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification