Prescription cancer drug lot recalled for failed quality specifications
Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—compromised drug purity and stability—but no adverse effects have been documented, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Fulvestrant Injection 250 mg/5 mL (50 mg/mL), a prescription medication used in cancer treatment. The product is administered by intramuscular injection and acts as an estrogen receptor antagonist. The affected lot is B200076 with an expiration date of January 31, 2024.
The recall was initiated because the affected lot failed to meet FDA specifications for impurities and degradation. These quality failures indicate the product may not be pure and stable as required.
The recalled lot was distributed nationwide. A total of 1,116 boxes of the affected product were identified in the recall.
Individuals who received medication from lot B200076 should verify their lot number with their pharmacy or healthcare provider. Those with questions can contact Zydus Pharmaceuticals or their healthcare provider for guidance.
The recalled product
- Product
- FULVESTRANT (FULVESTRANT)
- Brand
- FULVESTRANT
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Oncology
- Hazard
- impurity
- degradation
- manufacturing-defect
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 # B200076
- Exp 31 JAN 2024
Distribution
Distributed nationwide across the United States.
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