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.
Assured Aspirin Enteric Safety Coated Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
Drug: Aspirin Category: Pain Relief & OTC Medication
- Recalling firm
- American Family Pharmacy, LLC
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0040-2015 · 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
See all
Class I · High risk
Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Fw Aspirin Chewable Tablet 36ct Sku 913990 Gs Enteric Aspirin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
HPC Tablet
CGMP Deviations
Other wrong potency / content recalls from 2014
All wrong potency / content recalls
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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