SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.
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 severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 9,942 syringes of Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL). The product is a prescription-only, Schedule II controlled substance distributed in 5 mL single-dose syringes.
The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. The affected lots have expiration dates ranging from January 19, 2021, to February 8, 2021.
The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice and quarantine any affected units. Patients who have received this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 9,942
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 (19)
- Lot # 1220023040
- BUD 1/19/2021
- 1220023070
- BUD 1/21/2021
- 1220023105
- BUD 1/25/2021
- 1220023158
- BUD 1/26/2021
- 1220023315
- BUD 2/1/2021
- 1220023342
- BUD 2/2/2021
- 1220023431
- BUD 2/4/2021
- 1220023471
- BUD 2/3/2021
- 1220023481
- BUD 2/4/2021 & 1220023509
- BUD 2/8/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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