SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling 1,097 containers of Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL). The affected product is identified by NDC# 70004-0655-44 and Bar Code 70004065544.
The recall was initiated due to cross-contamination with other products. The containers are labeled as containing methylparaben and propylparaben as preservatives, but they actually contain undeclared benzyl alcohol and do not contain any parabens. The affected lots are 1220019269 and 1220019278 (Expiration 08/21/2020) and 1220019386 (Expiration 08/25/2020).
The product was distributed nationwide within the U.S. Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Affected units
- 1,097
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 (5)
- Lot #: 1220019269
- 1220019278
- Exp 08/21/2020
- 1220019386
- Exp 08/25/2020.
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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