Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Mibelas 24 Fe
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
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.
What was recalled
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
Affected NDCs
68180-0911-11
68180-0911-13
Compare with the code on your package — it is the most precise check available.
Drug: Estradiol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mibelas 24 Fe Norethindrone Acetate, Ethinyl Estradiol and Ferrous Fumarate NDC 68180-0911 |
Kit | Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Limited (Unit 1)
- NDC code
- 68180-911-11
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1093-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estradiol recalls
See all
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Other stability / shelf life recalls from 2017
All stability / shelf life recalls
Class II · Moderate risk
Dry to Normal Skin Starter Kit
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Day Cream SPF15 Cr¿me de jour FPS 15
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class II · Moderate risk
INFeD (Iron Dextran Injection USP)
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
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