EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Crystallization: Product appears to be turbid.
Reason Labelling: Incorrect Exp. Date
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals…
Reason Superpotent Drug
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals…
Reason Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count…
Reason cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason Failed Dissolution Specifications
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Reason Lack of sterility assurance.
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason Product Mix-up: Incorrect diluent component included in the kit.
Reason Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
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