The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0163-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG Powder Due to Sterility Concerns

Pharm D Solutions is recalling 114 vials of HCG 50,000 unit lyophilized powder nationwide due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 the hazard involves a lack of assurance of sterility in a medical product, which poses a risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Pharm D Solutions, LLC is recalling 114 vials of HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder (NDC 69699-1736-50). The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product was distributed nationwide. The recall includes specific lots with the following identifiers and discard dates: Lot 04092018:36 (Discard by 10/6/2018), Lot 05292018:93 (Discard by 11/25/2018), Lot 08062018:96 (Discard by 2/2/2019), and Lot 07022018:64 (Discard by 7/6/2018).

Consumers and healthcare providers should check their inventory for these specific lot numbers and discard dates. If the product is found, it should be removed from use and returned to the distributor or Pharm D Solutions, LLC.

The recalled product

Product
HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Biologic / Sterile Product
Hazard
Affected units
114

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: 04092018:36 Discard by: 10/6/2018
  • 05292018:93 Discard by: 11/25/2018
  • 08062018:96 Discard by: 2/2/2019
  • 07022018:64 Discard by: 7/6/2018

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

See all →

Same hazard · sterility

See all →

Similar recalls