Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Medroxyprogesterone Acetate Recalled for Sterility Concerns

Agency Publication Date: June 10, 2022

Summary

Sun Pharmaceutical Industries Inc. is recalling approximately 349,666 units of Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate), which is a medication typically used for birth control or treating certain hormonal conditions. The recall includes prefilled syringes and single-dose vials sold under the Afaxys Pharma, Northstar Rx, and Sun Pharmaceutical brands. This action was taken because the company cannot guarantee that the injectable liquid is sterile. No incidents or injuries have been reported to date, but the medication was distributed nationwide in the United States.

Risk

Injectable medications must be sterile because they bypass the body's natural defenses when administered. If the medication is contaminated with bacteria or other microorganisms due to a lack of sterility, it can cause severe infections at the injection site or life-threatening systemic infections.

What You Should Do

This recall affects Medroxyprogesterone Acetate Injectable Suspension, USP (150 mg/mL) in 1 mL prefilled syringes and single-dose vials sold under the Afaxys Pharma, Northstar Rx, and Sun Pharmaceutical brands.
Check your medication for the following NDC codes: 50102-591-40, 16714-999-01, 62756-091-40, 16714-981-01, or 16714-090-40.
Verify the lot number and expiration date on the individual syringe, vial, or carton. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for its return.
If you have health concerns or believe you have received an injection from one of these affected lots, contact your healthcare provider or pharmacist immediately.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Afaxys Pharma, LLC

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

JKX4312A (Exp 09/2022)

JKX4313A (Exp 09/2022)

JKX4827A (Exp 09/2023)

HAC1290A (Exp 06/2023)

HAC2082B (Exp 06/2023)

NDC:

50102-591-40

Manufactured by Sun Pharmaceutical Industries, Ltd. in India; Product of Italy.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Northstar Rx LLC

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

HAC1289A (Exp 06/2023)

JKX2679A (Exp 06/2022)

JKX3762A (Exp 08/2022)

HAC0164A (Exp 06/2023)

NDC:

16714-999-01

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Sun Pharmaceutical Industries, Inc.

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

HAC1951A (Exp 06/2023)

NDC:

62756-091-40

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial (150 mg/mL)by Northstar Rx LLC

Variants: 150 mg/mL, 1 mL Single-Dose Vial

Lot Numbers:

HAC2075A (Exp 06/2023)

HAC2076A (Exp 07/2023)

HAC2077A (Exp 08/2023)

HAC2078A (Exp 08/2023)

HAC3803A (Exp 09/2023)

HAC0551A (Exp 02/2023)

HAC0562A (Exp 03/2023)

HAC1183A (Exp 03/2023)

HAC1807A (Exp 06/2023)

JKX6017A (Exp 12/2022)

JKX6018A (Exp 12/2022)

HAC0163A (Exp 01/2023)

HAC1184A (Exp 04/2023)

HAC0162A (Exp 12/2022)

NDC:

16714-981-01

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial (25-Count Carton)by Sun Pharmaceutical Industries, Inc.

Variants: 150 mg/mL, 25 x 1 mL Single-Dose Vial

Lot Numbers:

HAC2074A (Exp 06/2023)

HAC0163B (Exp 01/2023)

HAC1741A (Exp 04/2023)

NDC:

16714-090-40

Packaged in 25-count carton. Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90151

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Afaxys Pharma, LLC; Northstar Rx LLC; Sun Pharmaceutical Industries, Inc.

Manufactured In: India, Italy, United States

Units Affected: 5 products (79339 syringes; 57997 syringes; 4625 syringes; 180813 syringes; 26892 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Medroxyprogesterone Acetate Injectable Suspension, USP (150 mg/mL) in 1 mL prefilled syringes and single-dose vials sold under the Afaxys Pharma, Northstar Rx, and Sun Pharmaceutical brands.

Check your medication for the following NDC codes: 50102-591-40, 16714-999-01, 62756-091-40, 16714-981-01, or 16714-090-40.

Verify the lot number and expiration date on the individual syringe, vial, or carton. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for its return.

If you have health concerns or believe you have received an injection from one of these affected lots, contact your healthcare provider or pharmacist immediately.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Affected Products

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Afaxys Pharma, LLC

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

JKX4312A (Exp 09/2022)

JKX4313A (Exp 09/2022)

JKX4827A (Exp 09/2023)

HAC1290A (Exp 06/2023)

HAC2082B (Exp 06/2023)

NDC:

50102-591-40

Manufactured by Sun Pharmaceutical Industries, Ltd. in India; Product of Italy.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Northstar Rx LLC

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

HAC1289A (Exp 06/2023)

JKX2679A (Exp 06/2022)

JKX3762A (Exp 08/2022)

HAC0164A (Exp 06/2023)

NDC:

16714-999-01

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe (150 mg/mL)by Sun Pharmaceutical Industries, Inc.

Variants: 150 mg/mL, 1 mL Prefilled Syringe

Lot Numbers:

HAC1951A (Exp 06/2023)

NDC:

62756-091-40

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial (150 mg/mL)by Northstar Rx LLC

Variants: 150 mg/mL, 1 mL Single-Dose Vial

Lot Numbers:

HAC2075A (Exp 06/2023)

HAC2076A (Exp 07/2023)

HAC2077A (Exp 08/2023)

HAC2078A (Exp 08/2023)

HAC3803A (Exp 09/2023)

HAC0551A (Exp 02/2023)

HAC0562A (Exp 03/2023)

HAC1183A (Exp 03/2023)

HAC1807A (Exp 06/2023)

JKX6017A (Exp 12/2022)

JKX6018A (Exp 12/2022)

HAC0163A (Exp 01/2023)

HAC1184A (Exp 04/2023)

HAC0162A (Exp 12/2022)

NDC:

16714-981-01

Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Product: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial (25-Count Carton)by Sun Pharmaceutical Industries, Inc.

Variants: 150 mg/mL, 25 x 1 mL Single-Dose Vial

Lot Numbers:

HAC2074A (Exp 06/2023)

HAC0163B (Exp 01/2023)

HAC1741A (Exp 04/2023)

NDC:

16714-090-40

Packaged in 25-count carton. Manufactured by Sun Pharmaceutical Industries Ltd. in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90151

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Afaxys Pharma, LLC; Northstar Rx LLC; Sun Pharmaceutical Industries, Inc.

Manufactured In: India, Italy, United States

Units Affected: 5 products (79339 syringes; 57997 syringes; 4625 syringes; 180813 syringes; 26892 vials)

Distributed To: Nationwide