Ortho-McNeil Reports Packaging Error on Birth Control Pill Dispensers

Ortho-McNeil Pharmaceutical Inc. (Raritan, NJ) has reported a packaging error affecting a small number of plastic refill rings used with its new, reusable compact-style birth control pill dispenser introduced this spring. The company currently estimates fewer than 60 refill rings containing the error could have reached the marketplace of the nearly five million distributed since May. This error could cause some women to take their pills in the wrong sequence. The error does not affect the pills.

Women should always begin their pill cycle with the pill marked "1." In the reusable compact, the refill ring should load with pill number "1" over the arrow on the center dial. A refill ring that contains the error will load with pill number "15" over the arrow. A new refill ring that has the error can still be used as long as a woman turns the dial to start her pill cycle with the pill marked "1."

The packaging error impacts two of the company's brands in the new, pink beige, reusable compact, available only from retail pharmacies and physician offices. The two brands are ORTHO TRI-CYCLEN (norgestimate/ethinyl estradiol) Tablets and ORTHO-CYCLEN (norgestimate/ethinyl estradiol) Tablets.

The error does not impact any other brands of Ortho-McNeil birth control pills or any Ortho-McNeil birth control pills distributed through college student health centers, community health centers and family planning clinics.

Manufacturing lots that could contain the packaging error were withdrawn from the marketplace voluntarily and replacement is under way. Ortho-McNeil has notified healthcare professionals, pharmacists, wholesalers and retailers. The FDA is aware of the company's actions. The company has identified and corrected the problem that led to the error.

Edited by Bill Noone