Bayer Recalls Estradiol Hemihydrate Powder Due to Cross Contamination
Bayer HealthCare Pharmaceuticals is recalling Estradiol Hemihydrate M20 EP/USP Powder due to cross contamination with another product. The affected lot was distributed in Kansas and California.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a Severe severity score per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Bayer HealthCare Pharmaceuticals Inc. is recalling Estradiol Hemihydrate M20 EP/USP Powder, packaged in 1.5 kg and 2.5 kg fiber drums. The product is prescription-only and manufactured by Bayer Pharma AG in Berlin. The recall is being conducted due to cross contamination with another product.
The recall involves Lot Number 81202450, which has an expiration date of 06/15/16. A total of 112.295 kg of the product was distributed in Kansas and California. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recall is limited to the specific lot number and distribution areas mentioned.
The recalled product
- Product
- Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer 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 (2)
- Lot Number: 81202450
- Exp 06/15/16
Distribution
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