Recall Enforment Report D-0075-2022
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Ultra Seal Corporation, originally initiated on 10-13-2021 for the product Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label) The product was recalled due to failed stability specifications: out-of-specification results observed for aspirin related compound salicylic acid.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0075-2022 | 10-13-2021 | 11-03-2021 | Class III | 991,310 tablets | Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0071-2022 | 10-13-2021 | 11-03-2021 | Class III | 1,367,525 tablets | 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) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0076-2022 | 10-13-2021 | 11-03-2021 | Class III | 42,394,018 tablets | Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0077-2022 | 10-13-2021 | 11-03-2021 | Class III | 519,600 tablets | Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0074-2022 | 10-13-2021 | 11-03-2021 | Class III | 250,000 tablets | North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917 | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0072-2022 | 10-13-2021 | 11-03-2021 | Class III | 1,968,150 tablets | ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0073-2022 | 10-13-2021 | 11-03-2021 | Class III | 1,480,981 tablets | 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 ) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |
D-0070-2022 | 10-13-2021 | 11-03-2021 | Class III | 2,484,274 tablets | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label) | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. | Terminated |