Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,700 syringes of midazolam HCl 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of loss of potency in a prescription medication.
Plain-English summary
Pharmedium Services, LLC is recalling 1,700 syringes of midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride. The product is a prescription-only medication packaged in 1 mL syringes. The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes.
The affected product is identified by Product code 2R3196. The specific lot numbers involved are 15124046M, 15125056M, 15127070M, 15127073M, 15138054M, 15147055M, 15149049M, 151880314M, and 151890307M. These lots have expiration dates ranging between 07/15/15 and 10/12/15. The recall is classified as FDA Class II.
The distribution of the affected product was nationwide. The primary hazard associated with this recall is the potential loss of potency in the medication. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recalled description.
The recalled product
- Product
- midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,700
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 (10)
- Lot Numbers: 15124046M
- 15125056M
- 15127070M
- 15127073M
- 15138054M
- 15147055M
- 15149049M
- 151880314M
- 151890307M
- 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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