D-0073-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- October 13, 2021
- Termination Date
- March 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,480,981 tablets
Product Description
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 )
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Distribution Pattern
Nationwide in the USA.
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.