Manufacturer Par Pharmaceuticals has issued a voluntary recall of various Gildess birth control products.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled various Gildess birth control products, with the knowledge of the FDA.
Which Gildess products were affected?
In this recall, 5 products were affected:
- Drugs: Gildess 1.5/30, Gildess FE 1.5/30, Gildess 1/20, Gildess FE 1/20, Gildess 24 FE.
- Manufacturer: Pan Pharmaceuticals
- National Drug Codes (NDC): 00603-7606-48, 00603-7606-15, 00603-7607-48, 00603-7607-15, 00603-7609-17, 00603-7608-17, 00603-7610-49, 00603-7610-17
Why have these products been recalled?
The recall was initiated because some products showed a reduction in the level of ethinyl estradiol. Low levels of ethinyl estradiol in birth control can lead to an increased probability of pregnancy and breakthrough bleeding.
Have any other generic birth controls similar to Gildess been affected?
No, at this time, only Gildess products have been affected by the recall.
When was the recall initiated?
Par Pharmaceuticals recalled these Gildess birth control products on September 28th, 2016.
What is Par Pharmaceuticals doing about this recall?
Par Pharmaceuticals is asking retailers to examine their inventory for recalled products, and stop dispensing the affected product(s) immediately.
Patients can return affected products directly to the pharmacy, or may arrange to return the product directly by calling Inmar at 1-800-967-5952, prompt #1 for recall.