Sandoz has recalled 10 lots of its generic oral contraceptive Introvale after package flaws were reported that could leave women at risk for unintended pregnancy. Within the blister packaging, the placebo tablets are potentially in the wrong order.
The recalled birth control pills were distributed between January 2011 and May 2012. A consumer reported that the white placebo tablets were mistakenly in the ninth row of the 13-row blister card, rather than in the correct position in the 13th and final row.
Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. The lot numbers included in this recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.
If a consumer finds a white placebo tablet in any position other than the 13th and final row they should immediately begin using a non-hormonal form of contraception. They should also contact their health care professional as well as Sandoz to report the finding at 800-525-2492, or by email at email@example.com.
Consumers and health care providers can also report adverse reactions or quality problems with the use of this product to the Food and Drug Administration's MedWatch Adverse Event Reporting program. Sandoz is not aware of any reports of related adverse events.
In February, Pfizer recalled 14 lots of its birth control pills Lo/Ovral-28, and 14 lots of the generic version Norgestrel and Ethinyl Estradiol, also because of tablets that were out of sequence, as well as inexact counts of inert or active ingredient tablets.
In the Pfizer case, 14 lots amounted to 1 million recalled packages of birth control. At this time, neither Sandoz nor the FDA has said how many birth control packets total are included in the 10 lot recall.
Sandoz US Announces Precautionary Recall Of Oral Contraceptive Introvale, Following Report Of Packaging Flaw [FDA]