Amneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
Amneal Pharmaceuticals is recalling 5,694 Exenatide Injection pens because the delivery system may be defective, potentially leaving the pen empty of medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (lack of medication) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling 5,694 pens of Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen. The recall is due to a defective delivery system that may result in no medication being present in the prefilled pen. The affected product is identified by Lot # AP250095A with an expiration date of 2/28/2027 and NDC 70121-1685-1.
The product was distributed nationwide in the United States. Exenatide is a prescription-only medication intended for subcutaneous use for single patient use only. It is manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.
Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should not be used. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatment options or replacement medication.
The recalled product
- Product
- EXENATIDE (EXENATIDE)
- Brand
- EXENATIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Prescription Injection
- Affected units
- 5,694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AP250095A
- Exp 2/28/2027
Distribution
Distributed nationwide across the United States.
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