Agency classClass IIOur severity:Severe FDA (Drugs)·D-0197-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.

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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL). The product is a CII, prescription-only medication packaged in 10 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 product was distributed to hospitals nationwide. The recall covers specific lots with expiration dates ranging from January 19, 2021, to February 9, 2021. The lot numbers involved are 1220023076, 1220023549, 1220023040, 1220023070, 1220023105, 1220023158, 1220023315, 1220023342, 1220023431, 1220023471, 1220023481, and 1220023509.

Hospitals and healthcare facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. Patients who have received this medication should contact their healthcare provider if they have any concerns or questions regarding their treatment.

The recalled product

Product: Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-cap
Affected units: 11,075

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 (20)

a) Lot # 1220023076
BUD 1/24/2021 & 1220023549
BUD 2/9/2021. b) 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

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.

See all 32 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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