SCA Pharmaceuticals Recalls Heparin Sodium Bags Due to Low Potency
SCA Pharmaceuticals is recalling 333 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (score 4) under the provided rubric, particularly given the subpotent nature of the drug.
Plain-English summary
SCA Pharmaceuticals is recalling 333 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, Lot # 1220017764, and an expiration date of June 24, 2020.
The recall was initiated because the product failed to meet potency specifications at the 30-day stability timepoint. This is classified as a subpotent drug issue.
The affected product was distributed to hospitals in Pennsylvania and California. No specific consumer action is detailed in the source text beyond the recall notice.
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
- Affected units
- 333
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 #: 1220017764
- exp. date June 24
- 2020
Distribution
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