The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1325-2019·Announced 2019-06-19

Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

Pharm D Solutions is recalling 279 vials of Human Chorionic Gonadotropin 5,000 IU due to a lack of sterility assurance. The recall covers products 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.

Plain-English summary

Pharm D Solutions, LLC is recalling 279 vials of Human Chorionic Gonadotropin 5,000 IU, a prescription-only medication. The recall was initiated due to a lack of sterility assurance in the product.

The affected lots are 01082019:88 (expiration date 07/06/2019) and 03182019:58 (expiration date 09/14/2019). These products were distributed nationwide within the United States.

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

The recalled product

Product
Human Chorionic Gonadotropin 5,000 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
279

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 #: 01082019:88 Exp. 07/06/2019
  • 03182019:58 Exp. 09/14/2019

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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