Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential loss of potency in a critical medication.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 4,407 syringes of atropine sulfate injection, 0.4 mg per mL (1 mg per 2.5 mL), for intravenous use. The recall is being conducted because stability data does not support the expiration dates for the product, which creates a potential risk of loss of potency in the medication.
The affected product is identified by product code 2R3324 and includes specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015. The recall is classified as FDA 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 recalled product was distributed nationwide. Healthcare providers and patients should discontinue use of the affected syringes and contact Pharmedium Services, LLC for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Affected units
- 4,407
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: 15146085M
- 15147088M
- 15149011M
- 15149109M
- 15150093M
- 151730001M
- 151740139M
- 151900018M
- 151910014M
- 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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