Recalls / Class II
Class IID-0229-2018
Product
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
- Brand name
- Doxorubicin Hydrochloride
- Generic name
- Doxorubicin Hydrochloride
- Active ingredient
- Doxorubicin Hydrochloride
- Route
- Intravenous
- NDCs
- 47335-049, 47335-050
- FDA application
- ANDA203263
- Affected lot / code info
- Lot # JKS0403A Exp 02/2019
Why it was recalled
Lack Of Assurance Of Sterility
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 393 vials
- Distribution pattern
- Product was distributed nationwide in the USA
Timeline
- Recall initiated
- 2018-01-16
- FDA classified
- 2018-01-19
- Posted by FDA
- 2018-01-31
- Terminated
- 2018-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0229-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.