CLASS I Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Vancomycin HCl added to 9% Sodium Chloride Bag For IV Use Only recalled
SCA Pharmaceuticals is recalling Vancomycin HCl added to 9% Sodium Chloride Bag For IV Use Only, distributed nationwide in the US. The recall was initiated on 3 Feb 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0641-2017
- FDA event ID
- 76395
- Recalling firm
- SCA Pharmaceuticals, Little Rock, AR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Feb 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 3 Feb 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +61 days |
| 12 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Vancomycin HCl added to 9% Sodium Chloride Bag For IV Use Only recalled?
Yes. SCA Pharmaceuticals recalled Vancomycin HCl added to 9% Sodium Chloride Bag For IV Use Only on 3 Feb 2017. The recall is Class I and its status is Terminated. Recall number D-0641-2017.
Why was it 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.
Which lots are affected?
Lot: 20161213@23, Exp 2/11/2017; Lot: 20161214@80, Exp 2/12/2017; Lot: 20161215@1, Exp 2/13/2017
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SCA Pharmaceuticals
All 166| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |