Class II · Moderate risk Ongoing
Alyacen 7/7/7
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Blisovi Fe 1.5/30
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
What was recalled
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-866-11
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0638-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
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Reason Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk Ongoing
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Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
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Reason Presence of Foreign substance - potential presence of metal particulate matter
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