Genzyme Recalls Thyrogen Injection Vials Due to Glass Particulate Matter
Genzyme Corporation is recalling 27,022 vials of Thyrogen (thyrotropin alfa) because glass particles were found in the product after reconstitution.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect (glass particles) in an injectable drug is categorized as Severe (Score 4), particularly given the risk of injury from particulate matter in an intramuscular injection.
Plain-English summary
Genzyme Corporation is recalling 27,022 vials of Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL, due to the presence of particulate matter. Specifically, glass particles were found in the product after reconstitution. The affected product is identified by Lot # E4029Y02 (carton) and E4029 (vial) with an expiration date of 09/2016.
The recalled product was distributed nationwide, as well as in Puerto Rico, Malaysia, Taiwan, Brazil, and Israel. Thyrogen is a prescription-only medication intended for intramuscular injection. Each carton contains four vials: two vials of Thyrogen and two vials of diluent.
Consumers and healthcare providers should stop using the affected vials immediately. Patients should contact their healthcare provider for further instructions or to obtain a replacement product. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC…
- Manufacturer
- Genzyme Corporation
- Category
- Drug — Injectable Prescription
- Affected units
- 27,022
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 #: E4029Y02 (carton)
- E4029 (vial) Exp 09/2016
Distribution
Part of a larger recall action
This product is one of 2 recalled by Genzyme Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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