The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0488-2022·Announced 2022-02-09

Pain Terminator Extra Strength Pain Relief Drug Recall

Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation without evidence of actual product harm or contamination. Class II recalls without health outcome reports typically fall into the Moderate category.

Plain-English summary

Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief tablets (containing aspirin 162 mg, acetaminophen 110 mg, caffeine 32.4 mg, and salicylamide 152 mg) distributed in 2-tablet packets. The product was manufactured for Tellus Medical Products, Palm Desert, California, with NDC number 69103-2507.

The recall was initiated on January 24, 2022, due to cGMP deviations identified during manufacturing. The affected lot is AK9451 with an expiration date of January 2022. Approximately 1,188,280 packets were distributed nationwide within the United States.

Consumers who have purchased this product should stop using it. The recall was voluntary and initiated by the firm with notification by letter. The FDA classified this as a Class II recall. The recall status was terminated on October 16, 2023.

The recalled product

Product
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Relief / Over-the-Counter
Hazard
Affected units
1,188,280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: AK9451
  • Exp. Date 01/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

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