SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling ePHEDrine Sulfate syringes due to a lack of assurance of sterility and potential for leaking.
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. According to the rubric, FDA Class II recalls with potential for significant harm (such as sterility issues in injectable drugs) are categorized as Severe.
Plain-English summary
SCA Pharmaceuticals is recalling ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), prescription only. The recall is due to a lack of assurance of sterility and the potential for the product to leak.
The affected product is identified by NDC# 70004-0600-11. Specific lots involved include 20170503@28 with a best-use date of 7/17/2017, and 20170508@60 with a best-use date of 7/22/2017. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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)
- Lots: 20170503@28 BUD: 7/17/2017
- 20170508@60 BUD: 7/22/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 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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