Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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