Teva Pharmaceuticals USA, Inc — Class II: Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured
Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for Metoclopramide Tablets, USP, 5 mg (100 and 500 count bottles) due to the presence of foreign tablets or capsules within the product containers. The recall is currently classified as ongoing.
This recall affects Teva Pharmaceuticals USA, Inc., specifically their manufacturing and distribution operations for Metoclopramide, as well as pharmacy staff and supply chain managers responsible for the affected NDC batches (0093-2204-01 and 0093-2204-05).
A Class II recall suggests that exposure to the foreign material may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote. For regulatory and QA professionals, this indicates a potential failure in line clearance, physical segregation during packaging, or automated inspection systems designed to identify non-conforming solid dosage forms. The presence of foreign tablets often prompts a review of Current Good Manufacturing Practice (cGMP) controls regarding multi-product facility management.
QA teams should evaluate existing vision system and manual inspection protocols for their ability to detect extraneous oral solid dosage forms. Manufacturing and packaging leads should perform a line clearance audit to ensure physical segregation protocols are sufficient to prevent cross-contamination or co-packaging of different products.
Class II. Reason: Presence of Foreign Tablets/Capsules. Product: Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05. Firm: Teva Pharmaceuticals USA, Inc (Parsippany NJ United States). Status: Ongoing.
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