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
Reported: January 31, 2018 Initiated: January 16, 2018 #D-0229-2018
Product Description
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
Reason for Recall
Lack Of Assurance Of Sterility
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 393 vials
- Distribution
- Product was distributed nationwide in the USA
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 393 vials.
Why was this product recalled? ▼
Lack Of Assurance Of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2018. Severity: Moderate. Recall number: D-0229-2018.
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