Recall due to report of packaging flaw
Sandoz is conducting a recall of 10 lots of its generic oral contraceptive Introvale® following a recent report of a packaging flaw. The probability of this packaging flaw causing serious adverse health consequences is remote and Sandoz is not aware of any reports of related adverse events.
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 in the United States between January 2011 and May 2012.
The recall was decided after a consumer reported 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. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.
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. Individuals with questions should contact their healthcare provider.
Any adverse events that may be related to the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program. The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500. The form may be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178.
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