Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Walgreens ASPIRIN FREE TENSION HEADACHE
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
Affected NDC
0363-0428-12
Compare with the code on your package — it is the most precise check available.
Drug: Acetaminophen Category: Pain Relief & OTC Medication
- Recalling firm
- LNK International, Inc.
- NDC code
- 0363-0428-12
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0319-2015 · 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 Acetaminophen recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
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.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Other recalls by LNK International, Inc.
All 2012 recalls
Class II · Moderate risk
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
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