FDA announces nationwide recall of epinephrine injections after reports of cracked vials
American Regent, Inc. has issued a voluntary nationwide recall for three lots of epinephrine injections following reports of cracked vials. The affected life-saving allergy products are USP 30 mg/30 mL at 1 mg/mL. The Ohio-based company initiated the recall due to contamination concerns involving particulate matter, which includes glass and nylon. Officials warn that this foreign matter can cause dangerous blood vessel blockages, clotting, organ damage, and potential death. Patients and healthcare providers are urged to check the list of affected products immediately.
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- ✓ American Regent, Inc. issued a voluntary nationwide recall of three lots of epinephrine injection, USP 30 mg/30 mL (1 mg/mL).
- ✓ The recall was prompted by reports of cracked vials and the presence of particulate matter, including glass and nylon.
- ✓ Particulate matter in injections can cause blockage and clotting in blood vessels, organ damage, or death.
What changed
American Regent, Inc. issued a voluntary nationwide recall for three specific lots of epinephrine injections.
Live updates
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FDA Announces Nationwide Recall of Epinephrine Injections
American Regent, Inc. has issued a voluntary nationwide recall for three lots of epinephrine injections following reports of cracked vials. The affected life-saving allergy products are USP 30 mg/30 mL at 1 mg/mL. The Ohio-based company initiated the recall due to contamination concerns involving particulate matter, which includes glass and nylon. Officials warn that this foreign matter can cause dangerous blood vessel blockages, clotting, organ damage, and potential death. Patients and healthcare providers are urged to check the list of affected products immediately.
Why it matters
Epinephrine is a critical, life-saving medication used to treat severe allergic reactions and anaphylaxis. The presence of physical debris such as glass inside injectable products poses an immediate safety hazard to patients. Regulatory agencies stepped in to alert the public and manage the withdrawal of the impacted merchandise from the supply chain.
What is confirmed
- American Regent, Inc. issued a voluntary nationwide recall of three lots of epinephrine injection, USP 30 mg/30 mL (1 mg/mL).
- The recall was prompted by reports of cracked vials and the presence of particulate matter, including glass and nylon.
- Particulate matter in injections can cause blockage and clotting in blood vessels, organ damage, or death.
What to watch next
- Updates on the specific lot numbers affected by the recall
- Instructions from healthcare providers on returning or exchanging recalled products
- Reports of any adverse events linked to the contaminated vials
confidence 100%Sources used for this update (9)
- WESH — FDA announces nationwide recall of epinephrine injections after reports of cracked vials
- USA Today — Epinephrine injections recalled. See list of affected products
- NTD News — Life Saving Allergy Shots Recalled Nationwide After Cracked Vials, Contamination Concerns
- The Sun Times News — Urgent Recall: American Regent Epinephrine Injection Warning
- Morningstar — American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
- gizmodo.com — Epinephrine Allergy Injections Recalled Over ‘Particulate Matter,’ Including Glass
- www.yahoo.com — American Regent recalls epinephrine injections over cracked vials
- www.wcvb.com — Video: Lowering humidity, mix of sun and clouds
- www.wbaltv.com — MTA bus collides with tree in Reisterstown leaving multiple people injured
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