Aurobindo Pharma USA Inc — Class II: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aur
Aurobindo Pharma USA Inc has initiated a Class II recall for Dicyclomine Hydrochloride Capsules (10mg) due to reports of shortfill and empty capsules. The recall covers 1,000 bottles of the prescription drug manufactured in India.
This recall affects Aurobindo Pharma USA Inc, its distribution partners, and pharmacy operations handling Dicyclomine Hydrochloride Capsules (NDC 59651-719-99). It specifically concerns manufacturing and quality control departments responsible for oral solid dosage forms.
The presence of empty capsules or shortfills suggests potential failures in the manufacturing or packaging weight-check processes. A Class II designation indicates that the product defect could cause temporary or medically reversible adverse health consequences, though the probability of serious consequences is remote. This event may prompt a review of the firm’s automated inspection systems and final product release criteria.
Quality teams should review encapsulation and filling line inspection protocols to ensure they are sufficient to detect empty shells or short-fill units. Supply chain partners should identify and quarantine affected NDC 59651-719-99 inventory. Manufacturing units may need to evaluate the root cause of the reported empty capsules within this batch.
Class II. Reason: shortfill; reports of empty capsules.. Product: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99. Firm: Aurobindo Pharma USA Inc (East Windsor NJ United States). Status: Ongoing.
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