medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
Reported: June 22, 2022 Initiated: May 6, 2022 #D-1144-2022
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
Reason for Recall
Lack of assurance of sterility
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 57997 syringes
- Distribution
- USA Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 57997 syringes.
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-1144-2022.
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