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Recall Observatory FDA recall evidence

Drug product

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

D-0852-2016

April 12, 2016

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 73812
Status
Terminated
Classification
Class II
Quantity
11,630 babs
Official record key
drug-enforcement:D-0852-2016

Official wording

Reason: Discoloration: presence of atypical yellow discoloration of the solution .

Code information: Lot # C989954, Exp 9/17

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration: presence of atypical yellow discoloration of the solution .