SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,221 syringes of Phenylephrine HCl 100 mcg/mL due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property-damage reports or high-risk scenarios.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 1,221 syringes of Phenylephrine HCl 100 mcg per mL in 0.9% Sodium Chloride. The product is a single-dose syringe with a 10 mL fill volume and a total dose of 1,000 mcg. The specific lot number is 20170920@53, and the beyond-use date is 12/19/2017.
The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk of infection if administered to patients.
The affected product was distributed nationwide in the United States. Healthcare providers and patients should stop using the recalled syringes and contact SCA Pharmaceuticals or their supplier for further instructions on returning the product.
The recalled product
- Product
- PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 1,221
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 (1)
- Lot: 20170920@53 BUD: 12/19/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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