# FDA recall D-1093-2017

> **Lupin Limited (Unit 1)** · Class I · drug recall initiated 2017-05-16.

## Product

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

## Reason for recall

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1093-2017
- **Recalling firm:** Lupin Limited (Unit 1)
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-16
- **Report date:** 2017-08-23
- **Termination date:** 2019-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pithampur, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1093-2017

## Citation

> AI Analytics. FDA recall D-1093-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1093-2017. Source: US FDA. Licensed CC0.

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