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.
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), 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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