The Recall Desk
ModerateFDA (Drugs)·D-1018-2018·Announced 2018-08-08

Vensun Pharmaceuticals Recalls Potassium Citrate Tablets Due to Breakage

Vensun Pharmaceuticals is recalling 3,683 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, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The specific defect is tablet breakage, which is a quality control issue rather than a high-risk contamination or structural defect leading to severe injury.

Plain-English summary

Vensun Pharmaceuticals, Inc. is recalling 3,683 bottles of Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles. The product is prescription-only and was manufactured by Strides Shasun Limited in India for Vensun Pharmaceuticals in Yardley, PA. The specific lot number is 9570012, with an expiration date of June 2019.

The recall was initiated because the tablets failed specifications due to tablet breakage. The affected 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 further instructions.

The recalled product

Product
POTASSIUM CITRATE (POTASSIUM CITRATE)
Brand
POTASSIUM CITRATE
Manufacturer
VENSUN PHARMACEUTICALS INC
Category
Drug — Prescription Drug
Hazard
Affected units
3,683

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 (2)

  • Lot #: 9570012
  • Exp. June-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

See all →