September 19, 2014

Maker recalls oral contraceptives

The following was received June 11, 2012, from Medco/Express Scripts:

On June 5 Sandoz announced it is conducting a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the U.S., following a recent report of a packaging flaw.

Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

The recall was decided after a consumer reported 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. Details on the recall are below: 

Product and strengths: Introvale (levonorgestrel and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg

Indication: prevent pregnancy

Manufacturer: Sandoz

Date of recall: June 5, 2012

Type of recall: voluntary, patient-level

Reason for recall: packaging error

NDCs of recalled products: NDC 00781 5584 36

Affected lot numbers: The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the U.S. between January 2011 and May 2012

Express Scripts patients impacted: approximately 240

Return/Replacement information: not yet available from Sandoz

Implications to Express Scripts and clients

 Express Scripts is taking the following action in response to this recall:

 · Calling impacted patients informing them about the recall and advising how to detect if they have impacted product. If the patient has affected product, Express Scripts will advise them to begin using a non hormonal form of contraception.

 · Advising patients to contact their doctor to discuss other concerns they may have and to obtain a new prescription for an alternative hormonal therapy because due to this recall, Introvale is currently not available.

 · Advising patients they may contact the Sandoz Drug Information Direct Line at 800-525-2492, 24 hours/day, seven days a week, or via email at qa.druginfo@sandoz.com. Specifics about return and reimbursement have not been released from the manufacturer.

 Developing/distributing a frequently asked questions document for pharmacists and customer service representatives.

Posting web messaging on www.medco.com.

Retail impact:

Retail patients will be managed by retail pharmacies according to their professional practices.