The U.S. Food and Drug Administration (FDA) announced on February 24 that Glenmark Generics USA, the North American division of Indian pharmaceutical company Glenmark Generics, Ltd., was voluntarily recalling seven lots of oral contraceptives at the consumer level. The recall is reportedly due to a packaging error, in which blisters were oriented incorrectly within the packaging for the tablets. This may cause the sequence of tablets to be incorrect, causing patients to take the tablets in the wrong order. This could therefore cause the overall treatment to be ineffective, leading to insufficient contraception and other health risks. The FDA recommends that anyone using oral contraceptives with the faulty packaging should immediately switch to a non-hormonal form of contraception.
Glenmark has not said how many total packages are affected by the recall, only the number of lots. It has said that a sufficient amount of the product is still available on the market, so the recall should not significantly impact the total supply. The tablets were reportedly manufactured by Glenmark in India and distributed by its North American division to retail pharmacies and wholesalers.
The affected products contain a mixture of Norgestimate and Ethinyl Estradiol in varying proportions. Both are hormones used in oral contraceptives, the treatment of menopause symptoms, and other conditions. Patients are instructed to take specific tablets at specific times during a 28-day period, and an interruption of the prescribed cycle can interrupt the contraceptives’ efficacy. The specific tablets covered by the recall, according to the FDA, contain tablets with doses of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg of the two compounds.
The FDA says that the packaging error does not pose any immediate health risks to women using the product. The principal risk, it says, is that unintended pregnancy could result from a lapse in contraceptive coverage resulting from the error. It could potentially pose health risks to people using oral contraceptives for non-contraceptive reasons, but that issue is not addressed by the FDA’s announcement.
Earlier in February, pharmaceutical company Pfizer also issued a recall of twenty-eight lots of similar generic tablets and brand-name Lo/Ovral-28 tablets. The tablets, manufactured by Pfizer and labeled under its Akrimax Pharmaceuticals brand, had similar packaging errors to the Glenmark product. Packaging on the Pfizer products might indicate the wrong sequence of tablets and contain inaccurate information on ingredients. Some tablets contain active ingredients and others only inert ingredients, and the sequence is critically important. The recall affected around 1 million packages.
Pharmaceutical companies and pharmacies play an important role in providing essential products for people’s health care. Oral contraceptives, as recent news has made clear, serve a number of important functions for patients. Errors in formulating, manufacturing, and packaging these products can have serious adverse impacts. Accordingly, the law holds companies and individuals liable for errors that lead directly to injuries in patients using these products.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.
More Blog Posts:
FDA Wants More Warning Label Information for Yaz, Pharmacy Error Injury Lawyer Blog, December 27, 2011
Study Shows Further Links between DES Exposure and Cancer in Women Exposed In Utero, Pharmacy Error Injury Lawyer Blog, October 19, 2011
FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury, Pharmacy Error Injury Lawyer Blog, May 9, 2011
Photo credit: ‘Plaquettes de pilule’ by Ceridwen (Own work) [CC-BY-SA-2.0-fr], via Wikimedia Commons