The Recall Desk
ModerateFDA (Drugs)·D-0831-2022·Announced 2022-05-11

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.

What this means for you

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
  • cgmp-deviation

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.

Related recalls

Same category