Annora Pharma Private Limited — Class II: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd
Annora Pharma Private Limited has initiated a Class II recall for Lacosamide Tablets, 100mg, due to the reported presence of a foreign tablet (Selexipag 1000 mcg) within a bottle. The recall involves 60-count bottles manufactured for Camber Pharmaceuticals.
This affects Annora Pharma Private Limited, Camber Pharmaceuticals, Inc., and stakeholders involved in the distribution and dispensing of Lacosamide Tablets USP 100mg (NDC 31722-813-60).
A product mix-up involving a controlled substance (Lacosamide) and a high-potency medication (Selexipag) suggests potential lapses in line clearance or cross-contamination controls. For regulatory professionals, this underscores the importance of stringent reconciliation processes during primary packaging, as mix-ups of different pharmacological classes represent a significant compliance risk.
QA teams should review line clearance protocols and visual inspection procedures for multi-product facilities. Supply chain managers should verify inventory against the specified NDC and lot information to ensure quarantine of affected 60-count bottles.
Class II. Reason: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.. Product: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.. Firm: Annora Pharma Private Limited (Hyderabad N/A India). Status: Ongoing.
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