The Recall Desk
ModerateFDA (Drugs)·D-1017-2018·Announced 2018-08-08

Vensun Recalls Potassium Citrate Tablets Due to Tablet Breakage

Vensun Pharmaceuticals is recalling 11,652 bottles of Potassium Citrate Extended-Release Tablets because they failed specifications due to tablet breakage.

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 due to tablet breakage, a physical defect that may cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for low-risk contamination or minor defects without reported serious injury.

Plain-English summary

Vensun Pharmaceuticals, Inc. is recalling 11,652 bottles of Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles. The product is a prescription-only medication manufactured by Strides Shasun Limited in India for Vensun Pharmaceuticals in Yardley, PA. The recall was initiated because the tablets failed specifications due to tablet breakage.

The affected product is identified by NDC 42543-408-01. Specific lots involved include Lot #9570024 (Exp. Jun-2019), Lot #9570027 and Lot #9570029 (Exp. Jul-2019), and Lot #7702088A and Lot #7702089A (Exp. Aug-2019). The product was distributed within the United States and Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
POTASSIUM CITRATE (POTASSIUM CITRATE)
Brand
POTASSIUM CITRATE
Manufacturer
VENSUN PHARMACEUTICALS INC
Category
Drug — Prescription Drug
Hazard
Affected units
11,652

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 (8)

  • Lot #: 9570024
  • Exp. Jun-2019
  • 9570027
  • 9570029
  • Exp. Jul-2019
  • 7702088A
  • 7702089A
  • Exp. Aug-2019.

UPCs (3)

  • 0342543408012
  • 0342543406018
  • 0342543407015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by VENSUN PHARMACEUTICALS INC 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 2 products in this recall →

Related recalls

Same brand · POTASSIUM CITRATE

Same hazard · tablet breakage

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