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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Northstar Rx Cyanocobalamin Injection Recalled for Glass Fragments

Agency Publication Date: July 16, 2024
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 432,250 vials of Cyanocobalamin Injection (Vitamin B12), USP, 1,000mcg/mL, which were manufactured for Northstar Rx LLC. The recall was issued because glass particulate matter was found in the medication vials. Consumers should stop using the affected medication immediately and contact their healthcare provider or the manufacturer to arrange for its return.

Risk

Injecting a drug containing glass fragments can cause serious health risks, including blood vessel damage, local inflammation, irritation, or the formation of a blockage in the bloodstream (embolism) that could lead to life-threatening organ damage.

What You Should Do

  1. This recall affects 1 mL multiple-dose vials of Cyanocobalamin Injection, USP, 1,000mcg/mL, sold under the Northstar Rx LLC label (NDC 16714-165-01). The affected products are marked with lot numbers L200253, L200281, and L200301, all with an expiration date of 07/31/2024.
  2. Stop using the recalled medication immediately.
  3. Contact Zydus Pharmaceuticals (USA) Inc or your drug distributor to arrange for the return of any remaining affected vials.
  4. If you have any health concerns or believe you have experienced symptoms related to the use of this injectable medication, contact your healthcare provider or pharmacist immediately.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this safety recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Cyanocobalamin Injection, USP, 1,000mcg/mL (1 mL Multiple-Dose Vial)by Northstar Rx LLC
Variants: 1,000mcg/mL, 1 mL Multiple-Dose Vial
Lot Numbers:
L200253 (Exp 07/31/2024)
L200281 (Exp 07/31/2024)
L200301 (Exp 07/31/2024)
NDC:
16714-165-01

Manufactured for Northstar Rx LLC, Memphis, TN; Recall Number D-0600-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94914
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Northstar Rx LLC
Manufactured In: India
Units Affected: 432250 vials
Distributed To: Tennessee

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 ยท 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.