Medications & Supplements/Prescription Drugs

Glenmark Fulvestrant, Naproxen, and Other Drugs Recalled for Sterility Risks

Agency Publication Date: September 21, 2021

Summary

Glenmark Pharmaceuticals Inc., USA is recalling approximately 313,762 units of various medications, including Fulvestrant (fulvestrant) Injection, Naproxen Sodium (naproxen) Tablets, Chlorzoxazone (chlorzoxazone) Tablets, Zonisamide (zonisamide) Capsules, and Arformoterol Tartrate (arformoterol) Inhalation Solution. The recall was initiated because some injectable and inhalation products may lack assurance of sterility, while others were produced with manufacturing deviations that violate current good manufacturing practices (CGMP). No incidents or injuries have been reported to date. These medications are used to treat various conditions, including cancer, pain, muscle spasms, seizures, and respiratory issues.

Risk

Sterile medications that lack sterility assurance pose a significant risk of infection if administered. Oral medications manufactured with deviations may have compromised quality or potency, which could lead to ineffective treatment or unexpected side effects.

What You Should Do

This recall affects Glenmark medications including Fulvestrant Injection, Naproxen Sodium Tablets, Chlorzoxazone Tablets, Zonisamide Capsules, and Arformoterol Tartrate Inhalation Solution.
Check the National Drug Code (NDC) and lot number printed on your medication's carton, bottle, or prescription label to see if it is included in this recall.
See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fulvestrant Injection 250 mg/5 mL (50 mg/mL)by Glenmark Pharmaceuticals Inc., USA

Variants: 250 mg/5 mL, Pre-filled syringes, Intramuscular use

Lot Numbers:

30200014 (Exp. 04/30/2022)

30200015 (Exp. 05/31/2022)

30200016 (Exp. 05/31/2022)

30200036 (Exp. 09/30/2022)

30200038 (Exp. 09/30/2022)

30200039 (Exp. 09/30/2022)

30200040 (Exp. 09/30/2022)

30210001 (Exp. 12/31/2022)

30210002 (Exp. 12/31/2022)

30210003 (Exp. 01/31/2023)

30210004 (Exp. 01/31/2023)

30210005 (Exp. 01/31/2023)

30210006 (Exp. 01/31/2023)

30210014 (Exp. 02/28/2023)

30210022 (Exp. 02/28/2023)

30210028 (Exp. 02/28/2023)

30210029 (Exp. 02/28/2023)

30210030 (Exp. 02/28/2023)

30210031 (Exp. 02/28/2023)

NDC:

68462-317-32

Contains 2 single-dose pre-filled syringes.

Product: Naproxen Sodium Tablets, USP 275 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 275 mg, Tablet

Lot Numbers:

29190087 (Exp. 10/31/2021)

29190088 (Exp. 10/31/2021)

29190089 (Exp. 10/31/2021)

29200077 (Exp. 11/30/2022)

29200078 (Exp. 11/30/2022)

NDC:

68462-178-01

Product: Naproxen Sodium Tablets, USP 550 mgby Glenmark Pharmaceuticals Inc., USA

Variants: 550 mg, Tablet, 100 Tablets, 500 Tablets

Lot Numbers:

29190082 (Exp. 09/30/2021)

29190083 (Exp. 09/30/2021)

29190084 (Exp. 10/31/2021)

29190085 (Exp. 10/31/2021)

29200001 (Exp. 12/31/2021)

29200003 (Exp. 01/31/2022)

29200004 (Exp. 01/31/2022)

29200005 (Exp. 01/31/2022)

29200012 (Exp. 02/28/2022)

29200013 (Exp. 02/28/2022)

29200010 (Exp. 02/28/2022)

NDC:

68462-179-01

68462-179-05

Product: Chlorzoxazone Tablets USP 375 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 375 mg, Tablet

Lot Numbers:

29200022 (Exp. 03/31/2022)

29200024 (Exp. 03/31/2022)

29200035 (Exp. 06/30/2022)

NDC:

68462-724-01

Product: Chlorzoxazone Tablets USP 750 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 750 mg, Tablet

Lot Numbers:

29200023 (Exp. 03/31/2022)

29200025 (Exp. 03/31/2022)

29200036 (Exp. 06/30/2022)

29200056 (Exp. 09/30/2022)

29200070 (Exp. 11/30/2022)

NDC:

68462-725-01

Product: Zonisamide Capsules USP 50 mg (100 Capsules)by Glenmark Pharmaceuticals Inc., USA

Variants: 50 mg, Capsule

Lot Numbers:

29190043 (Exp. 05/31/2022)

29190044 (Exp. 05/31/2022)

29190045 (Exp. 05/31/2022)

NDC:

68462-129-01

Product: Zonisamide Capsules USP 100 mgby Glenmark Pharmaceuticals Inc., USA

Variants: 100 mg, Capsule, 100 Capsules, 500 Capsules

Lot Numbers:

29200014 (Exp. 02/28/2023)

29200015 (Exp. 03/31/2023)

29200016 (Exp. 03/31/2023)

29200030 (Exp. 05/31/2023)

29200031 (Exp. 05/31/2023)

29200032 (Exp. 05/31/2023)

29200033 (Exp. 06/30/2023)

29200037 (Exp. 06/30/2023)

29200038 (Exp. 06/30/2023)

29200039 (Exp. 07/31/2023)

29200041 (Exp. 07/31/2023)

29200042 (Exp. 07/31/2023)

29200048 (Exp. 08/31/2023)

29200049 (Exp. 08/31/2023)

29200050 (Exp. 08/31/2023)

29200072 (Exp. 11/30/2023)

29200073 (Exp. 11/30/2023)

29200074 (Exp. 11/30/2023)

29200075 (Exp. 11/30/2023)

29200076 (Exp. 11/30/2023)

NDC:

68462-130-01

68462-130-05

Product: Arformoterol Tartrate Inhalation Solution 15 mcg/2 mLby Glenmark Pharmaceuticals Inc., USA

Variants: 15 mcg/2 mL, Inhalation Solution, 30x2 mL Vials, 60x2 mL Vials

Lot Numbers:

30210041 (Exp. 03/31/2023)

30210045 (Exp. 04/30/2023)

30210046 (Exp. 04/30/2023)

30210050 (Exp. 03/31/2023)

30210051 (Exp. 04/30/2023)

30210058 (Exp. 04/30/2023)

30210042 (Exp. 03/31/2023)

30210047 (Exp. 04/30/2023)

30210048 (Exp. 04/30/2023)

30210052 (Exp. 04/30/2023)

30210053 (Exp. 04/30/2023)

30210054 (Exp. 04/30/2023)

30210059 (Exp. 04/30/2023)

30210060 (Exp. 04/30/2023)

30210061 (Exp. 04/30/2023)

30210062 (Exp. 04/30/2023)

30210063 (Exp. 04/30/2023)

30210064 (Exp. 05/31/2023)

NDC:

68462-833-65

68462-833-35

Sterile Unit-Dose Vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88591

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 8 products (28658 cartons; 9552 bottles; a) 31248 bottles; b) 300 bottles; 1800 bottles; 4752 bottles; 15936 bottles; a) 216,454 bottles; b) 2166 bottles; a) 5362 inhalers; b) 5593 inhalers)

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 Glenmark medications including Fulvestrant Injection, Naproxen Sodium Tablets, Chlorzoxazone Tablets, Zonisamide Capsules, and Arformoterol Tartrate Inhalation Solution.

Check the National Drug Code (NDC) and lot number printed on your medication's carton, bottle, or prescription label to see if it is included in this recall.

See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fulvestrant Injection 250 mg/5 mL (50 mg/mL)by Glenmark Pharmaceuticals Inc., USA

Variants: 250 mg/5 mL, Pre-filled syringes, Intramuscular use

Lot Numbers:

30200014 (Exp. 04/30/2022)

30200015 (Exp. 05/31/2022)

30200016 (Exp. 05/31/2022)

30200036 (Exp. 09/30/2022)

30200038 (Exp. 09/30/2022)

30200039 (Exp. 09/30/2022)

30200040 (Exp. 09/30/2022)

30210001 (Exp. 12/31/2022)

30210002 (Exp. 12/31/2022)

30210003 (Exp. 01/31/2023)

30210004 (Exp. 01/31/2023)

30210005 (Exp. 01/31/2023)

30210006 (Exp. 01/31/2023)

30210014 (Exp. 02/28/2023)

30210022 (Exp. 02/28/2023)

30210028 (Exp. 02/28/2023)

30210029 (Exp. 02/28/2023)

30210030 (Exp. 02/28/2023)

30210031 (Exp. 02/28/2023)

NDC:

68462-317-32

Contains 2 single-dose pre-filled syringes.

Product: Naproxen Sodium Tablets, USP 275 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 275 mg, Tablet

Lot Numbers:

29190087 (Exp. 10/31/2021)

29190088 (Exp. 10/31/2021)

29190089 (Exp. 10/31/2021)

29200077 (Exp. 11/30/2022)

29200078 (Exp. 11/30/2022)

NDC:

68462-178-01

Product: Naproxen Sodium Tablets, USP 550 mgby Glenmark Pharmaceuticals Inc., USA

Variants: 550 mg, Tablet, 100 Tablets, 500 Tablets

Lot Numbers:

29190082 (Exp. 09/30/2021)

29190083 (Exp. 09/30/2021)

29190084 (Exp. 10/31/2021)

29190085 (Exp. 10/31/2021)

29200001 (Exp. 12/31/2021)

29200003 (Exp. 01/31/2022)

29200004 (Exp. 01/31/2022)

29200005 (Exp. 01/31/2022)

29200012 (Exp. 02/28/2022)

29200013 (Exp. 02/28/2022)

29200010 (Exp. 02/28/2022)

NDC:

68462-179-01

68462-179-05

Product: Chlorzoxazone Tablets USP 375 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 375 mg, Tablet

Lot Numbers:

29200022 (Exp. 03/31/2022)

29200024 (Exp. 03/31/2022)

29200035 (Exp. 06/30/2022)

NDC:

68462-724-01

Product: Chlorzoxazone Tablets USP 750 mg (100 Tablets)by Glenmark Pharmaceuticals Inc., USA

Variants: 750 mg, Tablet

Lot Numbers:

29200023 (Exp. 03/31/2022)

29200025 (Exp. 03/31/2022)

29200036 (Exp. 06/30/2022)

29200056 (Exp. 09/30/2022)

29200070 (Exp. 11/30/2022)

NDC:

68462-725-01

Product: Zonisamide Capsules USP 50 mg (100 Capsules)by Glenmark Pharmaceuticals Inc., USA

Variants: 50 mg, Capsule

Lot Numbers:

29190043 (Exp. 05/31/2022)

29190044 (Exp. 05/31/2022)

29190045 (Exp. 05/31/2022)

NDC:

68462-129-01

Product: Zonisamide Capsules USP 100 mgby Glenmark Pharmaceuticals Inc., USA

Variants: 100 mg, Capsule, 100 Capsules, 500 Capsules

Lot Numbers:

29200014 (Exp. 02/28/2023)

29200015 (Exp. 03/31/2023)

29200016 (Exp. 03/31/2023)

29200030 (Exp. 05/31/2023)

29200031 (Exp. 05/31/2023)

29200032 (Exp. 05/31/2023)

29200033 (Exp. 06/30/2023)

29200037 (Exp. 06/30/2023)

29200038 (Exp. 06/30/2023)

29200039 (Exp. 07/31/2023)

29200041 (Exp. 07/31/2023)

29200042 (Exp. 07/31/2023)

29200048 (Exp. 08/31/2023)

29200049 (Exp. 08/31/2023)

29200050 (Exp. 08/31/2023)

29200072 (Exp. 11/30/2023)

29200073 (Exp. 11/30/2023)

29200074 (Exp. 11/30/2023)

29200075 (Exp. 11/30/2023)

29200076 (Exp. 11/30/2023)

NDC:

68462-130-01

68462-130-05

Product: Arformoterol Tartrate Inhalation Solution 15 mcg/2 mLby Glenmark Pharmaceuticals Inc., USA

Variants: 15 mcg/2 mL, Inhalation Solution, 30x2 mL Vials, 60x2 mL Vials

Lot Numbers:

30210041 (Exp. 03/31/2023)

30210045 (Exp. 04/30/2023)

30210046 (Exp. 04/30/2023)

30210050 (Exp. 03/31/2023)

30210051 (Exp. 04/30/2023)

30210058 (Exp. 04/30/2023)

30210042 (Exp. 03/31/2023)

30210047 (Exp. 04/30/2023)

30210048 (Exp. 04/30/2023)

30210052 (Exp. 04/30/2023)

30210053 (Exp. 04/30/2023)

30210054 (Exp. 04/30/2023)

30210059 (Exp. 04/30/2023)

30210060 (Exp. 04/30/2023)

30210061 (Exp. 04/30/2023)

30210062 (Exp. 04/30/2023)

30210063 (Exp. 04/30/2023)

30210064 (Exp. 05/31/2023)

NDC:

68462-833-65

68462-833-35

Sterile Unit-Dose Vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88591

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies nationwide

Manufactured In: United States

Distributed To: Nationwide