Recalls / Class I
Class ID-1268-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
- Brand name
- Cefazolin Sodium
- Generic name
- Cefazolin Sodium
- Active ingredient
- Cefazolin Sodium
- Route
- Intravenous
- NDCs
- 0264-3103, 0264-3105, 0264-3107
- FDA application
- NDA050779
- Affected lot / code info
- Lot# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14; Lot# H3H507, Exp 01/15
Why it was recalled
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 136,392 units
- Distribution pattern
- Nationwide, Puerto Rico and Spain
Timeline
- Recall initiated
- 2013-11-21
- FDA classified
- 2014-04-25
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1268-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.