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.
What this means for you
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 III recall involving a stability/specification failure rather than a confirmed safety hazard with reported illness or injury. The source text does not indicate any actual illnesses, injuries, or deaths, making this a precautionary recall of the type typically classified as Moderate.
Plain-English summary
Ultra Seal Corporation is recalling AERO Tab PAIN RELIEVER tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide in the USA. The recall affects approximately 1,480,981 tablets in multiple lots with various expiration dates.
The recall was initiated due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, an Aspirin-related compound, indicating that the product did not meet required stability standards during testing.
Consumers who have purchased this product should stop using it. Those with questions or who may have been affected should contact their healthcare provider or the recalling firm, Ultra Seal Corporation.
The recalled product
- 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 )
- Manufacturer
- Ultra Seal Corporation
- Hazard
- failed-stability-specifications
- out-of-specification-results
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 (10)
- 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.
Distribution
Distributed nationwide across the United States.
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