SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers due to cross-contamination with undeclared benzyl alcohol.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 1,527 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL). The product is identified by NDC# 70004-0650-46 and Bar Code 70004065046. The affected lots are 1220019243 (Exp 08/20/2020), 1220019439, 1220019279, and 1220019392 (Exp 08/24/2020), and 1220019488 (Exp 08/26/2020).
The recall was initiated due to cross-contamination with other products. Specifically, containers labeled as containing methylparaben and propylparaben as preservatives were found to actually contain undeclared benzyl alcohol and did not contain any parabens. This discrepancy represents a significant labeling and formulation error for a prescription-only intravenous medication.
The affected product was distributed nationwide within the U.S. Healthcare providers and patients should check their inventory for the specific NDC, lot numbers, and expiration dates listed above. If the product is found, it should be quarantined and not administered. SCA Pharmaceuticals is the recalling firm responsible for managing this recall.
The recalled product
- Product
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Affected units
- 1,527
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 (8)
- Lot #: 1220019243
- Exp 08/20/2020
- 1220019439
- 1220019279
- 1220019392
- Exp 08/24/2020
- 1220019488
- Exp 08/26/2020.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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