Class II · Moderate risk
Aspirin Chewable tablet 81 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Low Dose ASPIRIN
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
Affected NDC
0536-1234-41
Compare with the code on your package — it is the most precise check available.
Drug: Aspirin Category: Pain Relief & OTC Medication
Product details
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 Low Dose Aspirin NDC 00536-1234 |
81 mg/1 | Tablet, Delayed Release Oral |
Rugby Laboratories | OTC |
- Recalling firm
- Cardinal Healthcare
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0170-2024 · FDA notice
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aspirin recalls
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Class I · High risk
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Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class III · Low risk
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Class II · Moderate risk
Fw Aspirin Chewable Tablet 36ct Sku 913990 Gs Enteric Aspirin…
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Class II · Moderate risk
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CGMP Deviations
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CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
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CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
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CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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