Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns
Anderson Compounding Pharmacy is recalling specific 60 mL syringes containing Heparin, Marcain, Sodium Bicarbonate, and Normal Saline due to a lack of sterility assurance.
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, an FDA Class II recall involving a risk of harm (lack of sterility assurance) without explicitly reported hospitalizations or fatalities falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant health risk.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 60 mL syringes containing a mixture of Heparin 10 mL, Marcain 0.25% 20 mL, Sodium Bicarbonate 8.4% 40 mL, and Normal Saline 5 mL. The recall was initiated because the product lacks sterility assurance.
The affected product is distributed nationwide. The recall covers all lots of this specific compounded syringe product. 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.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the product.
The recalled product
- Product
- Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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