Recalls / Class I
Class ID-0640-2017
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
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
- Affected lot / code info
- Lot: 20161228@65, Exp 02/26/2017; Lot: 20161214@76, Exp 02/12/2017
Why it was recalled
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 386 bags
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-02-03
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0640-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.