Cipla recalls 10mg/mL Phytonadione Injectable Emulsion vials due to stability problems. Check NDC numbers and batch dates for affected products.
Failed Stability Specifications: Observed OOS results: eg results for colour index
Cipla is recalling certain Phytonadione Injectable Emulsion vials because they failed stability tests. This means the medication may not be safe or effective once opened.
The vials failed stability tests, meaning the medication may lose effectiveness or become unsafe after opening. This could lead to incorrect dosing if the product is not stable.
People with prescriptions for Phytonadione Injectable Emulsion from Cipla USA, Inc. in Warren, NJ. Those using the product after the expiration date or with improper storage are at higher risk.
Check for NDC numbers 69097-708-31 (vial) and 69097-708-96 (carton). Products with batch numbers PH0072404A or PH0082404A and expiration date December 31, 2025 are affected.
Look for NDC numbers 69097-708-31 or 69097-708-96 and batch numbers PH0072404A or PH0082404A on the vial and carton.
The recall is due to stability issues, so the product may not be safe or effective once opened. Do not use affected vials.
Check the NDC numbers and batch dates: vial NDC 69097-708-31, carton NDC 69097-708-96, batch PH0072404A or PH0082404A, expiring December 31, 2025.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe disposal or alternatives.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0197-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0197-2026 from Cipla. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
