Pharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 12,173 syringes of ketamine HCl Injection because stability data does not support the expiration dates, posing a risk of reduced potency.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential loss of potency in a prescription medication.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 12,173 syringes of ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only (Product code 2R3348). The recall is being conducted because stability data does not support the expiration dates for the product, which may result in a potential loss of potency in the drug.
The affected product was distributed nationwide. The recall covers specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a refund. Patients should consult their healthcare provider regarding alternative treatments if necessary.
The recalled product
- Product
- ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 12,173
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)
- Lot Numbers: 15117083M
- 15117090M
- 15118047M
- 15121052M
- 15124079M
- 15126020M
- 15127007M
- 15127096M
- 15133014M
- 15133068M
- 15134067M
- 15139089M
- 15140069M
- 15141027M
- 15141043M
- 15142095M
- 15146008M
- 15149111M
- 15149116M
- 151730004M
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 recalled by Pharmedium Services, 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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