EMD Serono Recalls Cetrotide Vials Due to Missing Rubber Stoppers
EMD Serono is recalling 30,756 vials of Cetrotide because missing rubber stoppers could compromise sterility assurance.
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 classifies this as a Class II recall. Per the rubric, an FDA Class II recall involving a significant risk to sterility assurance (potential infection) is classified as Severe.
Plain-English summary
EMD Serono, Inc. is recalling 30,756 vials of Cetrotide (cetrorelix acetate for Injection) 0.25 mg. The product is a sterile, prescription-only medication intended for subcutaneous use only. The recall covers Lot # 8J025A and 8J025B, which have an expiration date of 09/30/2020.
The recall was initiated due to market complaints regarding missing rubber stoppers on the drug vials. The FDA classifies this as a Class II recall because the missing stoppers could lead to a lack of sterility assurance. The affected product was distributed nationwide in the US.
Patients and healthcare providers should stop using the affected vials and contact EMD Serono, Inc. for further instructions or a replacement.
The recalled product
- Product
- CETROTIDE (CETRORELIX ACETATE)
- Brand
- CETROTIDE
- Manufacturer
- EMD Serono, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 30,756
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 (3)
- Lot # 8J025A
- 8J025B
- Exp 09/30/2020
Distribution
Distributed nationwide across the United States.
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