FDA Recall D-0641-2017
SCA Pharmaceuticals · Little Rock, AR
Class I — life-threatening Terminated 258 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
Reason for recall
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall record
- Recall number
D-0641-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2017-02-03
- Classified by FDA Center
- 2017-04-05
- FDA published
- 2017-04-12
- Terminated
- 2017-10-19
- Recalling firm
- SCA Pharmaceuticals
- Firm location
- Little Rock, AR