SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL 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 recall is classified as FDA Class I, which meets the criteria for a Critical severity score (5) according to the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL). The affected product is identified by NDC#: 70004-0650-44, Bar Code 70004065044, Lot #: 1220019289, and an expiration date of 08/21/2020. The recall was initiated because the containers were labeled as containing methylparaben and propylparaben as preservatives, but actually contained undeclared benzyl alcohol and did not contain any parabens.
The affected product was distributed nationwide within the U.S. This recall is classified as Class I by the U.S. Food and Drug Administration. The source text does not specify the number of reported illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected product and contact SCA Pharmaceuticals or their healthcare provider for further instructions. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Affected units
- 366
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 #: 1220019289
- Exp 08/21/2020.
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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