medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
Reported: June 22, 2022 Initiated: May 6, 2022 #D-1147-2022
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
Reason for Recall
Lack of assurance of sterility
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 26892 vials
- Distribution
- USA Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 26892 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 June 22, 2022. Severity: Moderate. Recall number: D-1147-2022.
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