Check OC stock for Sandoz packaging flaw
Check your clinic storeroom for stock of the Sandoz oral contraceptive Introvale. The Princeton, NJ-based company issued a voluntary recall in June 2012 for 10 lots of the generic oral contraceptive following a recent report of a packaging flaw.
The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012.
The recall makes the third instance in seven months that oral contraceptives have been pulled from the market due to packaging errors. Qualitest of Huntsville, AL, pulled multiple lots of oral contraceptives Sept. 15, 2011, after the manufacturer detected a packaging error that could lead to incorrect administration of several brands of its pills. Pfizer of New York City issued a voluntary recall Jan. 31, 2012, of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of norgestrel and ethinyl estradiol tablets (generic) contraceptives packaged under the Akrimax label.
OC on market since 2011
Many clinicians might not be familiar with the product in question. Introvale, the generic equivalent of Seasonale, Teva Women' s Health' s extended oral contraceptive, just received Food and Drug Administration (FDA) approval in January 2011.
The company issued the voluntary recall following a consumer report that the white placebo tablets were mistakenly in the ninth row (labeled "Week 9") of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled "Week 13"). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.
"In the unlikely event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception," the company states in an official release. "They should also immediately contact their healthcare professional as well as Sandoz to report the finding via the Sandoz Drug Information Direct Line at (800) 525-2492, 24 hours/day, seven days a week, or via email at [email protected]."
The company also advises that patients or their healthcare provider may report adverse reactions or quality problems experienced with the use of the affected product to the FDA' s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. To report online, go to www.fda.gov/Safety/MedWatch/default.htm. On the left side of the page, under "Resources for You," select "Report A Serious Medical Product Problem Online" to access Form FDA 3500. Events may be entered online, or the form may be printed and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to (800) 332-0178. [Did you receive the Contraceptive Technology Update ebulletin on the recall? To receive future ebulletins, provide your e-mail address to AHC Media customer service at (800) 688-2421 or [email protected].]
Check your clinic storeroom for stock of the Sandoz oral contraceptive Introvale. The Princeton, NJ-based company issued a voluntary recall in June 2012 for 10 lots of the generic oral contraceptive following a recent report of a packaging flaw.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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