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Recall Observatory FDA recall evidence

Drug product

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59

D-0642-2017

February 03, 2017

Class I

Product summary

Firm
SCA Pharmaceuticals
Event
Event 76395
Status
Terminated
Classification
Class I
Quantity
490 bags
Official record key
drug-enforcement:D-0642-2017

Official wording

Reason: Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Code information: Lot: 20161212@44, Exp 2/10/2017; Lot: 20161230@40, Exp 2/28/2017

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter