Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 5,568 syringes of atropine sulfate injection because stability data does not support the expiration dates, posing a risk of reduced potency.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is recalling 5,568 syringes of atropine sulfate injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL total volume, for IV use. The product is identified by product code 2R3335 and specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015.
The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition may result in a potential loss of potency in the medication.
The affected products were distributed nationwide. Healthcare providers and patients should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 5,568
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 (15)
- Lot Numbers: 15146082M
- 15147001M
- 15147099M
- 15149110M
- 15150028M
- 15152055M
- 151730002M
- 151730129M
- 151880317M
- 151880330M
- 151890300M
- 151930022M
- 151940213M
- 151940288M
- 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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