FDA (Drugs) recall action 88843

Ultra Seal Corporation recalled 8 products on 2021-11-03

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2021-11-03
Critical: 0
Units: 51,455,858

Why these products were recalled

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Drugs)··2021-11-03
PainAway II Acetaminophen/Aspirin/Caffeine Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling PainAway II tablets nationwide due to failed stability specifications. Testing found out-of-specification levels of Salicylic Acid, an aspirin-related compound.
Product
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)
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-11-03
AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications
Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.
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 )
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-11-03
North by Honeywell Pain Stopper Extra Strength tablets recalled for failed stability
Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.
Product
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-11-03
Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.
Product
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)
Category
Distribution
0 states
LowFDA (Drugs)··2021-11-03
Vica-Cet Back Pain Relief tablets recalled for stability specification failure
Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.
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)
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-11-03
Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.
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)
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-11-03
Advance Formula Pain Reliever tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.
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 (Shippin
Category
Distribution
0 states
LowFDA (Drugs)··2021-11-03
ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications
Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).
Product
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 (Shi
Category
Distribution
0 states