Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Compare with the code on your package — it is the most precise check available.
Drug: Aspirin Category: Pain Relief & OTC Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Aspirin Chewable Aspirin 81 mg NDC 48433-0129 |
/1 | Tablet Oral |
Safecor Health, LLC | OTC |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Failed Tablet/Capsule Specification : Capsule breakage
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
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