American Health Packaging — Class II: Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: America
American Health Packaging has initiated a Class II recall for Metoclopramide Tablets, USP, 5 mg, packaged in 100-tablet unit dose cartons. The recall is due to the presence of foreign tablets or capsules within the product packaging.
This affects American Health Packaging, distributors of the specified NDC lots, and personnel responsible for pharmacy inventory management and quality control for oral solids.
The presence of foreign dosage forms suggests a potential breakdown in line clearance or packaging controls. While the source does not detail the nature of the foreign tablets, such incidents typically prompt a review of Current Good Manufacturing Practice (CGMP) compliance regarding cross-contamination and visual inspection effectiveness. The 'Ongoing' status indicates that reconciliation and recovery efforts are still active.
QA and production teams should review clearing procedures and line-clearance protocols to ensure equipment is free of foreign drug products between runs. Regulatory affairs should monitor for additional lot expansions and ensure communication with downstream distributors is maintained during the ongoing status of this recall.
Class II. Reason: Presence of Foreign Tablets/Capsules. Product: Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11. Firm: American Health Packaging (Columbus OH United States). Status: Ongoing.
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