A packaging error found in a blister pack of Estarylla birth control pills has led Sandoz USA to issue a recall, due to the potential risk that women may take placebos instead of the active tablets, leaving them unprotected against pregnancy.
The FDA announced the Estarylla recall on July 3, after a customer reported that at least one placebo tablet was in the incorrect row, mixed in with the active tablets. The recall will be issued at the retail level.
So far, this is the only incident reported by the company, however the recall was issued for the entire lot as a precaution. Sandoz says no adverse affects have been reported as a result of the error, and maintains that the risk of pregnancy from the packaging error is low, considering the flaw is easily visible before consuming the product.
Estarylla is manufactured for Sandoz by a third party manufacturer. Sandoz is a division of Novartis.
The recalled Estarylla (norgestimate and ethinyl estradiol) pills come from lot number LF01213A, with expiration date 02/2014 and NDC 00781-4058-15. It is supplied in cartons containing 3 blister cards of 28 tablets each, which was distributed within the US market only.
Ongoing Birth Control Manufacturing Problems
The Sandoz recall is one of many in a string of recent birth control pill recalls issued due to manufacturing problems that may leave women exposed to a risk of unwanted pregnancy.
Last month, Johnson & Johnson issued a recall of Cilest birth control pills after finding the drug had solubility issues, rendering it ineffective. Testing that led to the recall found one of the key active ingredients may dissolve too slowly. The ineffectiveness could result in unplanned pregnancy, with more than 32 million packages of birth control pills affected by the recall.
Earlier this year, a product liability lawsuit was filed against Qualitest Pharmaceuticals by a Missouri woman alleging she became pregnant after taking ineffective birth control pills manufactured by Qualitest which were a part of a 2011 recall. Those birth control pills were recalled after it was discovered that certain lots of Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem were packaged in reverse order, causing some women to take the pills in the incorrect order. The incorrect packaging placed the women at risk of pregnancy.
Officials recommend customers who are taking Estarylla birth control tablets contact their health care provider immediately if they feel they are at risk or have taken pills from a flawed package. Customers with questions can call the Sandoz Drug Information Direct Line at (800) 525-2492 or send an email to [email protected]