The Recall Desk
ModerateFDA (Drugs)·D-0293-2019·Announced 2018-12-19

CAO Group Recalls FastStat Topical Hemostat Kits Due to cGMP Violations

CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.

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, and the source text does not report any illnesses, injuries, or specific high-risk pathogens, aligning with the rubric for moderate severity involving manufacturing violations without reported harm.

Plain-English summary

CAO Group, Inc. is recalling 602 cartons of FastStat Topical Hemostat Introductory Kits, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. The product is identified by NDC 1406001003 and includes lot numbers 170626 (EXP 6/26/2019) and 171214 (EXP 1214/2019). The recall was initiated because current Good Manufacturing Practice (cGMP) violations were noted during the firm's most recent inspection.

The affected product was distributed nationwide in the US. The recall is classified as Class II by the FDA, indicating a situation where 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.

Healthcare providers and patients should stop using the affected product and contact their supplier or the recalling firm for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
Manufacturer
CAO Group, Inc.
Category
Drug — Topical Hemostat
Hazard
Affected units
602

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 (4)

  • Lot #: 170626
  • EXP 6/26/2019
  • 171214
  • EXP 1214/2019.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by CAO Group, 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 4 products in this recall →

Related recalls

Same manufacturer · CAO Group, Inc.

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Same hazard · cGMP violation

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