Recall Enforment Report D-0076-2022

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Ultra Seal Corporation, originally initiated on 10-13-2021 for the product 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) 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 ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0076-202210-13-202111-03-2021Class III42,394,018 tabletsXpect 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.Ongoing
D-0077-202210-13-202111-03-2021Class III519,600 tabletsAfassco 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.Ongoing
D-0073-202210-13-202111-03-2021Class III1,480,981 tabletsAERO 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.Ongoing
D-0074-202210-13-202111-03-2021Class III250,000 tabletsNorth 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 02917Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ongoing
D-0070-202210-13-202111-03-2021Class III2,484,274 tabletsPainAway 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.Ongoing
D-0075-202210-13-202111-03-2021Class III991,310 tabletsAdvance 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.Ongoing
D-0071-202210-13-202111-03-2021Class III1,367,525 tabletsVica-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.Ongoing
D-0072-202210-13-202111-03-2021Class III1,968,150 tabletsZEE+ 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.Ongoing