Drug recall: Vancomycin HCl injection bags for manufacturing deviations
SCA Pharmaceuticals has recalled Vancomycin HCl 1.5g injection bags due to manufacturing process deviations. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Voluntary firm-initiated recall for manufacturing process deviations without reported illnesses or adverse events. This matches the 'voluntary precautionary recalls' category at Moderate severity.
Plain-English summary
SCA Pharmaceuticals is recalling Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm.
The product was distributed nationwide within the United States. The affected lot is Lot #1222035839 with an expiration date of August 9, 2022. The recall affects 30 bags of this product (NDC 70004-0924-44).
The recall was initiated on April 25, 2022, and was terminated on September 9, 2022.
The recalled product
- Product
- Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug
- 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 #: 1222035839
- Exp. Date 09-Aug-22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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