Bayer Recalls Medroxyprogesterone Acetate API Due to Stability Failures
Bayer HealthCare Pharmaceuticals Inc. is recalling 194.62 kg of Medroxyprogesterone acetate API because it failed stability specifications for particle size.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure (particle size) with no reported injuries.
Plain-English summary
Bayer HealthCare Pharmaceuticals Inc. is recalling 194.62 kg of Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient. The product is packaged in 6.0 kg drums and is labeled as 6,000 kg. The specific lot number is 87100040.
The recall was initiated because the product failed stability specifications. Specifically, out-of-specification results for particle size were obtained at the 60-month test point. The agency has classified this recall as Class III.
The affected product was distributed in New York and California. No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 87100040
Distribution
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