The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1333-2019·Announced 2019-06-19

Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

Pharm D Solutions is recalling 100 vials of Sermorelin/GHRP-2 & 6 due to a lack of sterility assurance. The products were distributed nationwide in the United States.

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 involves a lack of sterility assurance, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharm D Solutions, LLC is recalling 100 vials of Sermorelin/GHRP-2 & 6 (3-3-3 MG). The recall was initiated because of a lack of sterility assurance in the product. The affected lot number is 12062018:17, with an expiration date of 06/04/2019.

The products were distributed nationwide within the United States. The recall is classified as Class II by the U.S. Food and Drug Administration.

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

The recalled product

Product
Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, 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
100

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 #: 12062018:17 Exp. 06/04/2019

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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