SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling Vancomycin HCl IV bags due to the presence of particulate matter, linked to a related Hospira recall.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
SCA Pharmaceuticals is recalling Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only. The product is identified by NDC 70004-0929-40, Lot 20161222@8, and an expiration date of 2/5/2017. The recall involves 30 bags distributed nationwide in the United States.
The recall is being conducted due to the presence of particulate matter. This action follows a recent recall by Hospira of vancomycin hydrochloride 10gm vials for the same issue. The FDA has classified this drug recall as Class I.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 20161222@8
- Exp 2/5/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by SCA Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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