Thyrogen recall: Particulate Matter
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton…
Why was Thyrogen recalled?
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
- Product
- Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton…
- Recalling firm
- Genzyme Corporation
- Quantity
- 4669 Cartons
- Distribution
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
- Recall date
- March 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)