Mibelas birth control pills have been recalled by Lupin Pharmaceuticals because the pills were packaged in the wrong order, giving users a chance for an unintended pregnancy.
A customer complained the Mibelas 24 Fe tablets were mismarked and packaged incorrectly, and the company confirmed that when the units were packaged the blister was rotated 180 degrees, reversing the weekly tablet positions and making the lot number and expiration date no longer visible.
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The first four days of the pills in the mismarked packages would have had four placebo tablets instead of four active tablets.
The company said the reversed order of the pills might not be apparent to new users or repeat users of the pills.
The pills recalled are Lot No. L600518 with expiration date 5/31/2018. The National Drug Code for the affected pills are:
- 68180-911-11 (Wallet of 28 tablets)
- 68180-911-13 (Carton of 3 wallets)
Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase.
Consumers with questions on the recall can contact Lupin by phone 1-800-399-2561 from 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.