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.
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 with no reported illnesses or injuries. The hazard is a failed stability specification for an aspirin-related compound, which represents a precautionary concern rather than an immediate safety threat with reported harm.
Plain-English summary
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets (containing Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg) due to failed stability specifications. Testing revealed out-of-specification results for Salicylic Acid, which is a compound related to Aspirin in the product.
The affected product consists of 519,600 tablets packaged in 2-tablet packets, distributed nationwide in the USA. The specific lot recalled is Lot #9819 or K-9819, with an expiration date of September 22.
Consumers who have purchased this product should stop using it and consult with their healthcare provider or pharmacist if they have any concerns about their health. The product should not be used.
The recalled product
- 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)
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Pain Reliever Tablets
- Hazard
- stability-failure
- out-of-specification-aspirin-metabolite
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 (3)
- Lot #: 9819
- K-9819
- exp. date 22-Sep
Distribution
Distributed nationwide across the United States.
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