Lupin Pharmaceuticals has voluntarily recalled one lot of its oral contraceptive Mibelas 24 F-E tablets after a consumer noticed a packaging error. The product was distributed nationwide to wholesalers, clinics and retail pharmacies.
Due to the packaging error, the oral contraceptive tablets taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy, according to a statement from Lupin. However, no adverse events has been reported to date.
The tablets are packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side.
National Drug Code (NDC) Lot No. Expiration
68180-911-11 (Wallet of 28 tablets) L600518 5/31/2018
68180-911-13 (Carton of 3 wallets) L600518 5/31/2018
Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase.
Consumers with questions regarding this recall can contact Lupin by phone 1-800-399-2561, 8 a.m. to 5 p.m. EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.