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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Northstar and Teva Injectable Medications Recalled for Sterility Concerns

Agency Publication Date: January 13, 2022
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Summary

Teva Pharmaceuticals USA is recalling 18,850 units of Methylprednisolone Acetate Injectable Suspension and Norepinephrine Bitartrate Injection. The recall was initiated because the products may not be sterile, which can lead to serious health complications. No incidents or injuries have been reported to date. These medications were distributed to hospitals and pharmacies in Mississippi, Ohio, and Tennessee.

Risk

Injectable medications that are not sterile can cause severe, life-threatening systemic infections. Because these drugs are administered directly into the body, any contamination poses a high risk to patient safety.

What You Should Do

  1. This recall affects 10 mL multiple-dose vials of Northstar Rx LLC Methylprednisolone Acetate Injectable Suspension (Lot 100022393, Exp 09/2022) and 4 mL single-dose vials of Teva Norepinephrine Bitartrate Injection (Lot 100020800, Exp 07/2022).
  2. Stop using the recalled injectable products immediately and quarantine any remaining inventory from the affected lots.
  3. Check the product packaging for NDC 16714-090-01 (Methylprednisolone) or NDC 0703-1153-03 (Norepinephrine) and the specific lot numbers listed above.
  4. Contact Teva Pharmaceuticals USA or your medical distributor to arrange for the return of the affected products.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Sterility assurance failure

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

Affected Products

Product: Methylprednisolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL)by Northstar Rx LLC
Variants: 10 mL Multiple-Dose Vial, 400 mg/10mL (40mg/mL)
Lot Numbers:
100022393 (Exp 09/2022)
NDC:
16714-090-01

Manufactured for Northstar Rx LLC; packaged in cartons.

Product: Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL)by Teva Pharmaceuticals USA
Variants: 4 mL Single-Dose Vial, 4 mg/4 mL (1 mg/mL)
Lot Numbers:
100020800 (Exp 07/2022)
NDC:
0703-1153-03

10 vials per carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89326
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Northstar Rx LLC; Hospitals; Pharmacies
Manufactured In: United States
Units Affected: 2 products (7,400 cartons; 11,450 vials)
Distributed To: Tennessee, Mississippi, Ohio

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.