Sun Pharmaceutical Recalls Doxorubicin Hydrochloride Injection Due to Sterility Concerns
Sun Pharmaceutical Industries is recalling 393 vials of Doxorubicin Hydrochloride Liposome Injection due to a lack of assurance of 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (sterility failure in an injectable drug) corresponds to a severity score of 4 (Severe).
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 393 vials of Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial. The product is identified by Lot # JKS0403A with an expiration date of 02/2019 and NDC 47335-049-40.
The recall was initiated due to a lack of assurance of sterility. The product was distributed nationwide in the USA. The drug is a human prescription drug intended for intravenous use.
Healthcare providers and patients should stop using the affected product and contact Sun Pharmaceutical Industries, Inc. for further instructions or returns.
The recalled product
- Product
- DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
- Brand
- DOXORUBICIN HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 393
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 (1)
- Lot # JKS0403A Exp 02/2019
UPCs (1)
- 0347335050400
Distribution
Distributed nationwide across the United States.
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