Drug product
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
D-0073-2022
Product summary
- Event
- Event 88843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,480,981 tablets
- Official record key
drug-enforcement:D-0073-2022
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Code information: Lot #: K-1278, exp. date 23-Jul; K-9371, AK-9463, exp. date 21-Nov; AK-9821, AK-9819, exp. date 22-Sep; 1107, exp. date 23-Mar.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification