Drug recall

Antibacterial Sulfamethazine Sustained Release Calf Bolus (72 hours). NADA 120-615. Net Contents: 50 boluses…

FDA recall event 53870 · Class II · Bimeda, Inc.

Key facts

Event ID 53870
Recall numbers V-014-2010
Recalling firm Bimeda, Inc.
Product type Veterinary
Products Antibacterial Sulfamethazine Sustained Release Calf Bolus (72 hours). NADA 120-615. Net Contents: 50 boluses. Each Bolus Contains: Sulfamethazine (formulated in a sustained release base) 123.8 grains…
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall During routine stability testing, Sustain Calf Lot 13330220 was discovered to have failed dissolution testing. Some of the boluses dissolve faster than the specification of not more than 60% dissolved…
Initiation date Nov 6, 2009
Termination date Oct 7, 2011
City Le Sueur
State MN
Country United States
FEI number 2110168

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports

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