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Amneal Pharmaceuticals of New York, LLC: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by

DrugsSource: FDA (drug) · Date: 2026-09-30

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Amneal Pharmaceuticals of New York, LLC
Product
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
Reason / hazard
Defective Delivery System: Possibility of no medication in the prefilled pen.
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-08-28
Code info
Lot #: AP250095A, Exp 2/28/2027
Product quantity
5,694 pens
Voluntary mandated
Voluntary: Firm initiated
City
Brookhaven
State
NY
Country
United States
Event id
99762
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