Teva Recalls Romidepsin Injection Vials Due to Impurity Failures
Teva Pharmaceuticals is recalling 1,416 vials of Romidepsin Injection because stability testing revealed out-of-specification impurities.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 1,416 vials of Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL), NDC 0703-4004-01. The recall was initiated because out-of-specification results were observed for impurities during stability testing. The affected product is distributed nationwide in the USA.
The specific lots subject to this recall are Lot # 31328184C (exp. 11/2021), Lot # 31327686C (exp. 08/2021), and Lot # 31327685C (exp. 08/2021). The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and patients should discontinue use of the affected lots and contact Teva Pharmaceuticals USA for further instructions or to arrange for returns.
The recalled product
- Product
- Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Antineoplastic
- Hazard
- Affected units
- 1,416
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 (4)
- Lot # 31328184C
- exp. date 11/2021 Lot # 31327686C
- exp. date 08/2021 Lot # 31327685C
- exp. date 08/2021
Distribution
Distributed nationwide across the United States.
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