Amneal Pharmaceuticals, LLC — Class II: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharm
Amneal Pharmaceuticals, LLC has initiated a Class II recall for Estradiol Gel, 0.1% (0.25 mg) due to defective containers, specifically packets that were found to be empty or only partially full.
This recall affects Amneal Pharmaceuticals, LLC, distributors of NDC 69238-2452-3, and quality/manufacturing personnel responsible for topical gel sachet production and weight verification.
Empty or partially full packets lead to sub-therapeutic dosing, which is a significant clinical concern for prescription hormone therapies. From a regulatory perspective, this suggests a failure in automated fill-weight monitoring or final container-closure integrity checks during the packaging process. The ongoing status indicates that reconciliation and root cause analysis may still be in progress.
QA teams should review in-process weight-check protocols for sachet/packet filling lines to ensure detection of under-filled or empty units. Manufacturing teams should investigate potential equipment calibration errors or sensor failures that allowed empty primary packaging to reach final carton assembly.
Class II. Reason: Defective Container; packets were found to be either empty or partially full.. Product: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.. Firm: Amneal Pharmaceuticals, LLC (Bridgewater NJ United States). Status: Ongoing.
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