Teva Pharmaceuticals USA, Inc — Class II: traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia
Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for Trazodone Hydrochloride Tablets, USP, 50 mg, due to the presence of foreign tablets or capsules within the product containers. The affected units were manufactured in Croatia by Pliva Hrvatska d.o.o. and distributed in 100-count bottles.
This recall affects Teva Pharmaceuticals USA, Pliva Hrvatska d.o.o., and pharmaceutical professionals involved in the distribution, dispensing, and quality oversight of generic trazodone hydrochloride.
The presence of foreign dosage forms indicates a potential failure in line clearance or physical segregation during the manufacturing and packaging process. From a regulatory perspective, this suggests an excursion from cGMP standards related to finished product integrity, which may necessitate an investigation into site-specific equipment cleaning or sorting procedures at the Croatian facility.
QA teams should evaluate the effectiveness of visual inspection and packaging controls at the Zagreb manufacturing site. Supply chain managers should verify batch segregation protocols to prevent cross-contamination or co-mingling during the packaging of multi-product portfolios.
Class II. Reason: Presence of Foreign Tablets/Capsules. Product: traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01. Firm: Teva Pharmaceuticals USA, Inc (Parsippany NJ United States). Status: Ongoing.
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