Multi-event October 2021 FDA Recall Drug by Ultra Seal Corporation

This Multi-event Class III drug recall was voluntarily initiated by Ultra Seal Corporation on October 13, 2021 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0077-2022 TERMINATED D-0074-2022 TERMINATED D-0073-2022 TERMINATED D-0070-2022 TERMINATED D-0076-2022 TERMINATED D-0075-2022 TERMINATED D-0071-2022 TERMINATED D-0072-2022 TERMINATED

Recall Number: D-0077-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
519,600 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# : 9819, K-9819, exp. date 22-Sep

Recall Number: D-0074-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
250,000 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : AK-9371, exp. date 21-Nov

Recall Number: D-0073-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
1,480,981 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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 )

Batch or Lot Expiration 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.

Recall Number: D-0070-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
2,484,274 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# : AK-9336, exp. date 21-Oct; K9406, AK-9407, exp. date 21-Dec; K-9860, exp. date 22-Oct; AK-1057, exp. date 23-Feb

Recall Number: D-0076-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
42,394,018 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of 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)

Batch or Lot Expiration Information

Lot# : K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun

Recall Number: D-0075-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
991,310 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of 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)

Batch or Lot Expiration Information

Lot# : AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan

Recall Number: D-0071-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
1,367,525 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# : AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep

Recall Number: D-0072-2022

Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Initiated
10-13-2021
Reported
11-03-2021
Quantity
1,968,150 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88843
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultra Seal Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2022
Product Description About Product Description
Full technical description of the 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 (Shipping Label)

Batch or Lot Expiration Information

Lot# : AK-9547, exp. date 22- Apr; AK-9941, exp. date 22-Dec