This morning, I got a call from a pharmacist from a fertility pharmacy which supplies our patients with their medications. As much as my staff tried to triage the call, he refused to divulge any information to them and insisted on talking directly to me only. When I finally took his call, he informed me that a batch of progesterone had tested positive for potential non-sterility so they were issuing a voluntary recall. We had received one vial and he gave me the patient’s name. I was relieved it was her, because she is in the middle of stimulation for IVF, and therefore, she has not started taking her progesterone yet. The pharmacist said that they would immediately contact her about getting the vial back, so they can swap out a new one. I told him we will follow up from our end to make sure that goes smoothly.
I asked for clarification and learned a little bit more about their quality control process. Bear in mind that progesterone in oil is one that is compounded by the pharmacy as opposed to something like Gonal-F, Follistim or Bravelle which are produced in huge pharmaceutical plants. It was reassuring to know that even the smaller pharmacies had regular mechanisms to insure safety. He shared with me that 2% of each batch is routinely sent for testing. They do 14-day tests to check for contamination from bacteria (aerobic and anaerobic) as well as fungus. They also test the medication for potency. This particular batch tested positive for anaerobic contamination on day 13 of the 14 day watch-period. He said that usually, when a sample is truly contaminated, it grows out positive in the first 48 hours, before they even ship out the product. But this one didn’t turn positive until day #13, making it likely to be just a false positive due to contamination at the testing laboratory. It was also unusual in that it was the anaerobic test that was positive. He added that since a small amount of an antibiotic agent is routinely added to the progesterone as part of the recipe, they don’t usually see anaerobic bacteria growing out. In any case, even though it was probably a false alarm, they were doing the prudent thing by recalling the batch.
It’s nice to know what’s going on behind the scenes to keep our medication safe.
