The Recall Desk
SevereFDA (Drugs)·D-0343-2019·Announced 2018-12-26

Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharm D Solutions is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU due to inadequate processes to assure 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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in a sterile product is categorized as Severe.

Plain-English summary

Pharm D Solutions, LLC is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU, a prescription-only medication. The product is identified by NDC 69699-1738-10, Lot 10292018:21, with an expiration date of 3/31/2019.

The recall was initiated because of a lack of assurance of sterility. The source text indicates that the manufacturer used inadequate processes and equipment to assure the sterility of products intended to be sterile.

The affected product was distributed in Washington (WA). Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions at 1-844-263-6843 for further instructions.

The recalled product

Product
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Sterile
Hazard
Affected units
85

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 (1)

  • Lot: 10292018:21 Exp. 3/31/2019

Distribution

Distributed in 1 state:

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