The Recall Desk
ModerateFDA (Drugs)·D-0830-2022·Announced 2022-05-11

Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations

SCA Pharmaceuticals voluntarily recalled 424 bags of fentanyl and bupivacaine injectable solution due to manufacturing control deviations. The product was distributed nationwide in the United States.

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: This is an FDA Class II recall with no reported illnesses or injuries mentioned in the source. The identified hazard—CGMP deviations in pharmaceutical manufacturing—is a quality control issue classified as Moderate severity under the recall rubric for voluntary precautionary recalls without reported adverse events.

Plain-English summary

SCA Pharmaceuticals has voluntarily recalled 424 bags of fentanyl 2mcg/ml and bupivacaine 0.125% in 0.9% sodium chloride injectable solution (NDC 70004-0231-32). The product was distributed nationwide within the United States. The recall was initiated on April 25, 2022, due to current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

The affected product includes two lot numbers: Lot #1222035837 (expiration July 22, 2022) and Lot #1222035804 (expiration July 25, 2022).

This is a voluntary recall initiated by the firm. The FDA classified this recall as Class II. Patients or healthcare providers who possess this product should consult their healthcare provider regarding continued use. The recall was terminated on September 9, 2022.

The recalled product

Product
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable Pharmaceutical
Hazard
Affected units
424

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 (3)

  • Lot #: 1222035837
  • Exp. Date 22-Jul-22 Lot #: 1222035804
  • Exp. Date 25-Jul-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.

See all 3 products in this recall →

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