Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 545 syringes of morphine sulfate 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, as it involves a potential loss of potency in a potent opioid medication.
Plain-English summary
Pharmedium Services, LLC is recalling 545 syringes of morphine sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use. The product is identified by Product code 2R3353. The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes.
The affected lots are 15118049M, 15126025M, 15131016M, 15133030M, 15139058M, 15140053M, 15142047M, 15146041M, 15147034M, 15149046M, 151720071M, 151880293M, and 151930114M. These lots have expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide.
The primary hazard is a potential loss of potency in the medication. Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and returned to the manufacturer or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific product.
The recalled product
- Product
- morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Opioid Analgesic
- Hazard
- Affected units
- 545
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 (14)
- Lot Numbers: 15118049M
- 15126025M
- 15131016M
- 15133030M
- 15139058M
- 15140053M
- 15142047M
- 15146041M
- 15147034M
- 15149046M
- 151720071M
- 151880293M
- 151930114M
- 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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