The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1324-2019·Announced 2019-06-19

Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

Pharm D Solutions is recalling Human Chorionic Gonadotropin 10,000 IU vials due to a lack of sterility assurance. The recall affects 26 vials distributed nationwide.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the provided text, the classification and the nature of the defect (sterility) align with the Severe criteria for Class II recalls.

Plain-English summary

Pharm D Solutions, LLC is recalling 26 vials of Human Chorionic Gonadotropin 10,000 IU, prescription only. The recall is being conducted due to a lack of sterility assurance in the product.

The affected product is identified by Lot # 02052019:42 with an expiration date of 08/03/2019. The product was distributed nationwide within the United States.

Consumers should stop using the product and contact Pharm D Solutions at 1-844-263-6846 for further instructions.

The recalled product

Product
Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
26

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 #: 02052019:42 Exp. 08/03/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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 18 products in this recall →

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