Agency classClass IIOur severity:High FDA (Drugs)·D-1495-2020·Announced 2020-08-19

SCA Pharmaceuticals Recalls Heparin Sodium Bags Due to Low Potency

SCA Pharmaceuticals is recalling 3,932 bags of Heparin Sodium 5,000 units due to out-of-specification potency results at the 30-day stability timepoint.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. While the rubric suggests Class II with hospitalization reports is Severe (4), this specific recall cites out-of-specification potency without reported hospitalizations or injuries, aligning with the High (3) criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 3,932 bags of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only. The product is identified by NDC 70004-0650-46. The recall was initiated because the drug failed to meet potency specifications at the 30-day stability timepoint.

The affected lots include 1220018755, 1220018861, 1220018850, 1220018899, 1220019027, 1220019075, 1220019243, 1220019439, 1220019279, 1220019392, and 1220019488. These lots have expiration dates ranging from July 30, 2020, to August 26, 2020. The product was distributed nationwide within the United States.

Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Manufacturer: SCA Pharmaceuticals
Category: Drug — Anticoagulant
Hazard: subpotent-drug
Affected units: 3,932

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 (19)

Lot #: 1220018755
Exp. Date 7/30/2020
1220018861
1220018850
Exp. Date 8/4/2020
1220018899
Exp. Date 8/5/2020
1220019027
Exp. Date 8/11/2020
1220019075
Exp. Date 8/12/2020
1220019243
Exp. Date 8/20/2020
1220019439
1220019279
1220019392
Exp. Date 8/24/2020
1220019488
Exp. Date 8/26/2020

Distribution

Distributed nationwide across the United States.

Same manufacturer · SCA Pharmaceuticals

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