Glenmark Generics Recalls 7 Lots of Oral Contraceptives

Larry Hand

Disclosures

February 27, 2012

February 27, 2012 — Glenmark Generics USA announced on February 24 a nationwide voluntary recall of 7 lots of its norgestimate and ethinyl estradiol oral contraceptives because of a packaging error.

The following lots are affected:

  • 04110101, expiration date July 31, 2013;

  • 04110106, expiration date July 31, 2013;

  • 04110107, expiration date July 31, 2013;

  • 04110114, expiration date August 31, 2013;

  • 04110124, expiration date August 31, 2013;

  • 04110129, expiration date August 31, 2013; and

  • 04110134, expiration date September 30, 2013.

Women who have tablets from the 7 lots, listed in the company's announcement, should contact their physician and return the tablets to the pharmacy, the manufacturer said in a statement. The company recommended that women "exposed to affected packaging should begin using a non-hormonal form of contraception immediately."

The company did not reveal how many packages are in each lot, or the total number of packages involved in its recall, but said a sufficient supply of products unaffected by this recall remains on the market.

Because of the packaging error, "the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," the company said in its announcement. Some blister packs were rotated 180 degrees, "reversing the weekly tablet orientation," the manufacturer stated.

The error left the lot number and expiration date visible only on the outer pouch of the monthly packages; this recall applies to any blister pack that does not show a lot number and expiration date.

The correct packaging configuration consists of 3 pouch packs in a carton. Each pouch pack has 1 blister pack with 28 tablets, comprising 7 tablets in 4 rows, with colors going from white to off-white in the top row, light blue, and blue active tablets located above light green inert tablets in the bottom row.

Glenmark Generics Ltd in India manufactured the tablets, and Glenmark Generics USA distributed them in the United States between September 21 and December 30, 2011.

On February 1, Pfizer Inc voluntarily recalled 14 lots of its similar norgestrel and ethinyl estradiol oral contraceptive tablets commercialized by Akrimax Rx Products and marketed under the brand name Lo/Ovral-28, also because of a packaging error.

To report adverse events related to these oral contraceptives, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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