Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial – Lot # R2200232 due to Product Mix-Up / 23 Dec 2022

Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level.

Accord received a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.”

The lot number, NDC number and expiration date of affected Daptomycin 500 mg/vial and Daptomycin 350 mg/vial product is shown in the table below:

It is typical to have reduced change over cleaning and line clearance requirements when different strengths of a product manufactured / packed in same line. Companies should evaluate, perform risk assessment and implement systems, procedures to prevent product mixups, with adequate line clearance procedures for change over, adequate batch /lot segregation, in process labelling, control on dispensing, issuance, handling of printed packing materials – labels, cartons, outer cartons.

• Different strengths of the product should carry different lot numbers
  
• Robust line clearance procedures for change over between different strengths (fill volume) in both manufacturing (vial filling, lyophilisation), labelling and packing lines. If labelling and packing is performed offline, all vials after filling and lyophilisation should be collected, counted, reconciled and securely stored (bulk intermediate storage) with proper labelling and identification. Line clearance procedure by production and quality assurance using checklist which ensure all previous product related articles (vials, labels, cartons, tools) are all removed from the area before commencing operations.
• Robust line clearance procedure for labelling and packing lines. All articles related to previous batch (vials, labels, cartons, tools) should be removed from the line, verified against a checklist by production and QA and certified.
• Robust procedure, documentation with reconciliation if there are practices of secondary packing materials being issued in excess (and excess is returned to stores or stored by production day store after packing).
• Consider having different size / shape vials for different strengths, fill volumes; different size or color/ artwork for secondary packing materials (inner and outer cartons). This will help controls like checkweigher, camera to reject wrongly packed cartons.
• Robust procedure for examination of vials, cartons for labelling, overprinting. Qualify the personnel involved, perform online challenge tests with induced errors, rotation of persons.

• Investigate the incident and establish root cause (s) and probable root causes. Document the same. Take corrective actions for all probable causes.
• Evaluate whether similar root cause(s) can affect other batches. If no elaborate the rationale. This can be performed only when a proper investigation of the event is performed, probable causes identified, and project possible causes identified on other products and assess possibility of similar lapses. Accordingly take requisite actions (e.g – recall, stop distribution etc).
• Recall of affected lots, other potential lots which could be impacted.
• Review and improve procedures, checklists, practices for line clearance for manufacturing lines, packing lines, label reconciliation. Consider the different procedural actions and practices discussed in above sections  – vial size, carton size and colour, other engineering controls, qualification of personnel involved in checking and inspection, physical examination, procedures for dispensing, issuance, handling of labels and packing materials.
• Improve procedures batch handling and segregation, identification, lot  / batch numbering.