Lupin Recalls Mibelas 24 Fe Contraceptive Tablets Due to Sequence Error
Lupin Limited is recalling Mibelas 24 Fe tablets because the first four pills in the packet are brown instead of the last four, and the expiry/lot was not printed on the package.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of at least 4. The defect involves a sequence error in a contraceptive product, which is a significant risk of harm.
Plain-English summary
Lupin Limited is recalling Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets. The recall involves 24,652 tablets distributed nationwide. The specific batch number is L600518 with an expiration date of 05/18.
The recall was initiated because the first four pills of the packet are brown, instead of the last four pills, and the expiry/lot was not printed on the package. This is a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only and was distributed by Lupin Pharmaceuticals, Inc., in Baltimore, MD.
The recalled product
- 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…
- Manufacturer
- Lupin Limited (Unit 1)
- Category
- Drug — Contraceptive
- Affected units
- 24,652
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch Number L600518
- Exp. 05/18
Distribution
Distributed nationwide across the United States.
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