Teva Pharmaceuticals Recalls Mixed Amphetamine Salts Tablets Over Mixed Strengths
Teva Pharmaceuticals USA, Inc. initiated a Class II recall for 33,280 bottles of its Mixed Amphetamine Salts Tablets due to mixed strengths within bottles. This voluntary action, terminated in May 2021, highlights critical quality control vulnerabilities impacting product efficacy and patient safety. Procurement and regulatory teams must scrutinize supplier quality systems for similar high-risk products.
FDA Class II Recall: Teva Pharmaceuticals' Mixed Amphetamine Salts Product
Teva Pharmaceuticals USA, Inc. initiated a Class II recall, designated D-1285-2020, for its Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. This specific product, a Mixed Amphetamine Salts formulation, was packaged in 5 mg, 100-count bottles, identified by NDC 0555-0971-02. The recall, voluntarily initiated by the firm on May 22, 2020, stemmed from a critical quality issue: some bottles were found to contain mixed strengths of the product. This poses a significant risk to patient safety, as incorrect dosing can lead to either sub-therapeutic effects or overdose, particularly concerning for a controlled substance like amphetamine salts. For procurement directors, this incident underscores the imperative of stringent quality assurance protocols at contract manufacturing organizations (CMOs) and internal production sites. The presence of mixed strengths within a single bottle indicates a breakdown in packaging or sorting processes, demanding immediate review of validation and in-process controls. Regulatory affairs heads must recognize that a Class II classification signifies that the product’s use or exposure may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This classification dictates the urgency and scope of corrective actions required.
Operational Footprint and Distribution Impact of Teva's Recall
The recalled product, specifically Lot #: 42614718 with an expiration date of February 2021, involved a substantial quantity of 33,280 bottles. Teva Pharmaceuticals USA, Inc., with its recalling firm address at 400 Interpace Pkwy, Parsippany, NJ 07054-1120, managed the recall. While the product label indicated North Wales, PA 19454 as the manufacturer, the recall was coordinated from the Parsippany location. The distribution pattern for these affected Mixed Amphetamine Salts Tablets was nationwide within the United States and Puerto Rico, indicating a broad market exposure. For business development executives, this widespread distribution highlights the potential for significant market disruption and reputational damage when quality incidents occur. Supply chain VPs must assess their inventory across all distribution points, utilizing the specific product NDCs (0555-0775, 0555-0971, 0555-0972, 0555-0776, 0555-0777, 0555-0973, 0555-0974) to identify and quarantine affected stock. The broad reach into both the continental U.S. and Puerto Rico means that patient populations across diverse healthcare systems were potentially exposed, necessitating comprehensive communication and retrieval strategies. This event emphasizes the need for robust traceability systems capable of pinpointing affected batches across complex distribution networks.
Regulatory Resolution and Supply Chain Stability for Amphetamine-Based Therapies
The recall of Teva Pharmaceuticals USA, Inc.'s Mixed Amphetamine Salts Tablets was initiated voluntarily by the firm, with initial notification provided via letter. This proactive approach, while firm-initiated, was subsequently classified by the FDA on June 4, 2020. The recall process concluded with a termination date of May 25, 2021, indicating that the FDA was satisfied with the corrective actions taken and the effectiveness of the recall efforts. For regulatory affairs heads, the termination signifies the successful resolution of the immediate compliance issue, but the underlying root causes of the mixed-strength bottles must be thoroughly addressed to prevent recurrence. Procurement directors sourcing similar controlled substances or multi-strength products should view this event as a critical data point in supplier qualification and ongoing performance monitoring. While the recall is terminated, the incident itself underscores the fragility of supply chains when quality control falters. The absence of specific alternative suppliers in our intelligence graph for this particular event means that any disruption could have a direct impact on the availability of this essential medication. Supply chain VPs must consider the potential for short-term market shortages and evaluate their contingency plans for high-demand, high-risk pharmaceutical products, especially those with limited known alternative sources.