The Recall Desk
SevereFDA (Drugs)·D-1159-2019·Announced 2019-04-24

Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns

Anderson Compounding Pharmacy is recalling 12 syringes of a Heparin, Marcain, and Sodium Bicarbonate mixture 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a medical product, which meets the rubric criteria for a Severe rating.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling 12 syringes of a compounded mixture containing Heparin 10 mL, Marcain 0.25% 20 mL, and Sodium Bicarbonate 8.4% 40 mL per 70 mL. The recall is being conducted due to a lack of sterility assurance for the product.

The affected product was distributed nationwide. The recall covers all lots of this specific compounded mixture. 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 return or dispose of the medication.

The recalled product

Product
Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Affected units
12

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.

See all 68 products in this recall →

Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

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