The Recall Desk
HighFDA (Drugs)·D-0156-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG Lyophilized Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable because the product lacks assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen risk (lack of sterility) for an injectable product, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Pharm D Solutions, LLC is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable (NDC 69699-1707-10) due to a lack of assurance of sterility. The affected product is distributed nationwide.

The recall involves specific lots with discard dates ranging from October 21, 2018, to January 28, 2019. The source text does not report any illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions or a refund.

The recalled product

Product
HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
2,219

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 (6)

  • Lot: 04252018:33 Discard by: 10/21/2018
  • 05082018:39 Discard by: 11/4/2018
  • 06262018:00 Discard by: 12/23/2018
  • 07192018:13 Discard by: 1/15/2019
  • 08012018:46 Discard by: 1/28/2019
  • 08212018:69 Discard by: 11/30/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC 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 79 products in this recall →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

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Same hazard · sterility

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