The Recall Desk
SevereFDA (Drugs)·D-0161-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG 3000 Unit Powder Due to Sterility Concerns

Pharm D Solutions is recalling 765 vials of HCG 3000 Unit Powder nationwide due to a lack of assurance of sterility.

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 assurance of sterility, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

Pharm D Solutions, LLC is recalling 765 vials of HCG 3000 Unit Powder (NDC 69699-1738-10) distributed nationwide. The recall was initiated because of a lack of assurance of sterility for the product.

The affected lots are 03262018:79 with a discard by date of 9/22/2018, and 08212018:75 with a discard by date of 2/17/2019. 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 and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.

The recalled product

Product
HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
Hazard
Affected units
765

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: 03262018:79 Discard by: 9/22/2018
  • 08212018:75 Discard by: 2/17/2019

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 →