The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1332-2019·Announced 2019-06-19

Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns

Pharm D Solutions is recalling 66 vials of Sermorelin/GHRP-2 because they lack sterility assurance. The products were 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a lack of sterility assurance which poses a significant risk, are categorized as Severe (Score 4).

Plain-English summary

Pharm D Solutions, LLC is recalling 66 vials of Sermorelin/GHRP-2 9 mg/6 mg, a prescription-only medication. The recall was initiated because the products lack sterility assurance.

The affected vials were distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in 2019.

Consumers who have these products should stop using them and contact Pharm D Solutions at 1-844-263-6846 for further instructions.

The recalled product

Product
Sermorelin/GHRP-2 9 mg/6 mg 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
66

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 #: 03052019:43 Exp. 08/31/2019
  • 04042019:15 Exp. 10/01/2019
  • 04172019:08 Exp. 08/31/2019
  • 05022019:47 Exp. 10/30/2019
  • 05082019:78 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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