The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0160-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 881 vials of HCG Lyopholized 1200 IU Injectable 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of whether specific injuries are reported in the text.

Plain-English summary

Pharm D Solutions, LLC is recalling 881 vials of HCG Lyopholized 1200 IU Injectable (NDC 69699-1743-12) distributed nationwide. The recall was initiated because of a lack of assurance of sterility for the product.

The affected lots include 04092018:58 (discard by 10/6/2018), 06072018:03 (discard by 12/4/2018), 05292018:86 (discard by 11/25/2018), 07192018:64 (discard by 1/15/2019), and 08302018:30 (discard by 2/26/2019). The U.S. Food and Drug Administration has classified this as a Class II recall.

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 Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
881

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 (5)

  • Lot: 04092018:58 Discard by: 10/6/2018
  • 06072018:03 Discard by: 12/4/2018
  • 05292018:86 Discard by: 11/25/2018
  • 07192018:64 Discard by: 1/15/2019
  • 08302018:30 Discard by: 2/26/2019

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 →

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