Genzyme Recalls Thyrogen Due to Glass Particles Found in Product
Genzyme Corporation is recalling specific lots 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, FDA Class II recalls with potential for significant injury or adverse health consequences (such as injection of glass particles) are rated as Severe (4).
Plain-English summary
Genzyme Corporation is voluntarily recalling 4,669 cartons of Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL, under NDC 58468-0030-2. The recall is due to the presence of particulate matter, specifically glass particles, found in the product after reconstitution.
The affected lots are E4029Y03, E4029Y04, E4029Y06, and E4029Y07, all with an expiration date of 12/2017. The product was distributed nationwide, as well as in Puerto Rico, Malaysia, Taiwan, Brazil, and Israel. Thyrogen is a prescription medication intended for intramuscular injection only.
Healthcare providers and patients should stop using the affected lots immediately. Patients should contact their healthcare provider for further instructions or alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- THYROGEN (THYROTROPIN ALFA)
- Brand
- THYROGEN
- Manufacturer
- Genzyme Corporation
- Category
- Drug — Prescription Injection
- Affected units
- 4,669
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 (5)
- Lot #s: E4029Y03
- E4029Y04
- E4029Y06
- E4029Y07
- Exp 12/2017
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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