Dr. Reddy's Recalls Docetaxel Injection Due to Vial Seal and Cap Defects
Dr. Reddy's Laboratories is recalling 5,755 vials of Docetaxel Injection due to seal and cap defects that may compromise sterility.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect (loss of sterility assurance) poses a significant risk of harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 5,755 vials of Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL), One-Vial Formulation. The recall affects Lot H7081 with an expiration date of 07/2019. The product was distributed nationwide in the USA.
The recall was initiated due to complaints regarding seal and cap vial issues. These defects could lead to a lack of sterility assurance, which is a critical quality attribute for intravenous medications.
Healthcare providers and patients should stop using the affected vials and contact Dr. Reddy's Laboratories for further instructions or returns. The FDA has classified this recall as Class II, indicating a situation in which exposure to, or use of, a 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 — Antineoplastic
- Affected units
- 5,755
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#: H7081
- Exp 07/2019
Distribution
Distributed nationwide across the United States.
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