Pharmedium Recalls Ketamine HCl Injection Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 54 syringes of ketamine HCl injection because stability data does not support the expiration dates, posing a risk of reduced drug 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. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant potential health impacts such as loss of drug potency.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 54 syringes of ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe. The product is prescription-only and intended for intravenous use. The recall involves specific lot numbers (15117045M, 15120050M, 15131014M) with expiration dates between 07/15/15 and 10/12/15.
The recall was initiated because stability data does not support the expiration dates for drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. 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.
The affected product was distributed nationwide. Healthcare providers and patients who have this specific product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 54
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 (4)
- Lot Numbers: 15117045M
- 15120050M
- 15131014M
- Exp between 07/15/15-10/12/15
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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