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Birth Control Pills Recall

Timely Insights on Laws, Issues and New Developements

Seven lots of Glenmark Generics generic birth control pills Norgestimate and Ethinyl Estradiol have been recalled due some blister packs putting the tablets in the wrong order, causing the pills to be ineffective.
The recall includes oral contraceptives distributed nationwide between September 21 and December 30, 2011.  The mistake was discovered when a consumer of the pills told Glenmark the tablets in her package were in reverse order.
The blister packaging on the recalled pills was rotated 180 degrees, causing the pills to be in the reverse order.  The expiration date of the recalled pills is only visible on the outer pouch.  Any blister pack with no lot number or expiration date is subject to recall.
Consumers using the recalled pills should immediately begin using a non-hormonal form of contraception and notify their physician immediately.  The recalled pills should be returned to the pharmacy that administered them.

The lot numbers of recalled Norgestimate and Ethinyl Estradiol tablets (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg) are as follows:

NDC: 68462-565-29

  • Lot number 04110101, expiration 7/31/2013
  • Lot number 04110106, expiration 7/31/2013
  • Lot number 04110107, expiration 7/31/2013
  • Lot number 04110114, expiration 8/31/2013
  • Lot number 04110124, expiration 8/31/2013
  • Lot number 04110129, expiration 8/31/2013
  • Lot number 04110134, expiration 9/30/2013

Adverse events related to this recall can be reported to Glenmark Generics at (888) 923-7001 (8 a.m. to 5 p.m. Mon-Fri EST) or to the Food and Drug Administration’s MedWatch Program.


by Matthews & Associates

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