Multi-event August 2020 FDA Recall Drug by Ultra Seal Corporation
This Multi-event Class III drug recall was voluntarily initiated by Ultra Seal Corporation on August 3, 2020 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1513-2020
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
08-03-2020
08-26-2020
701,735 packets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
03-16-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Batch or Lot Expiration Information
Lot# : K-8909, AK8909, Exp. Date 12/2020; AK9507, Exp. Date 03/2021; AK9072, Exp. Date 04/2021; AK9102, AK9601, AK9679, Exp. Date 05/2021; AK9145, K9145, Exp. Date 06/2021; AK9743, AK9830, Exp. Date 07/2021; AK9276, Exp. Date 09/2021; AK9391, A9392, Exp. Date 12/2021; AK9505, Exp. Date 02/2022; AK9508, AK9509 Exp. Date 04/2022
Recall Number: D-1512-2020
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
08-03-2020
08-26-2020
4,666,355 packets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
03-16-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Batch or Lot Expiration Information
Lot# : AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
