Dr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects
Dr. Reddy's is recalling 1,051 vials of Docetaxel Injection USP due to defects in the vial seals that may allow the stopper to detach.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall, and the source text describes a container defect without reporting specific injuries or illnesses, aligning with the rubric for moderate severity.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,051 vials of Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation. The affected product is identified by Lot # H7044 and has an expiration date of 05/19. The product was distributed nationwide in the USA, as well as in Uzbekistan and Myanmar.
The recall was initiated due to product complaints regarding a defect in the vial seals. Specifically, the aluminum seal and/or stopper may be removed when the cap is flipped off. This defect could potentially compromise the integrity of the container.
Healthcare providers and patients should stop using the affected vials and contact Dr. Reddy's Laboratories, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DOCETAXEL (DOCETAXEL)
- Brand
- DOCETAXEL
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injection
- Affected units
- 1,051
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 #: H7044
- Exp 05/19
Distribution
Distributed nationwide across the United States.
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