Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
Compare with the code on your package — it is the most precise check available.
Drug: Caffeine
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.
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
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