SCA Pharmaceuticals Recalls Ketamine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 922 syringes of Ketamine 50 mg/5 mL injection due to a lack of assurance of sterility. The product was distributed nationwide.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the potential for serious harm from non-sterile injections in a Class II drug recall aligns with the Severe criteria.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 922 syringes of Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use. The product is identified by NDC 70004-0430-09, Lot # 1219010961, and an expiration date of 10/24/2019.
The recall was initiated due to a lack of assurance of sterility. The affected product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 922
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 #: 1219010961
- Exp. 10/24/2019
Distribution
Distributed nationwide across the United States.
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