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.
ZEE Aspirin 325mg - 24 tablets in single dose packets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product 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
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
Drug: Aspirin Category: Pain Relief & OTC Medication
- Recalling firm
- Zee Medical Products Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0041-2015 · 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.
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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
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Class I · High risk
Slim-K
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Class II · Moderate risk
Ginseng Kianpi Pil
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class II · Moderate risk
MAYHEM capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class I · High risk
Forever Beautiful BEE POLLEN
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
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