The Recall Desk
ModerateFDA (Drugs)·D-0718-2022·Announced 2022-03-30

Sermorelin Acetate Injectable Recalled for Sub-Potent Strength

Olympia Compounding Pharmacy is recalling Sermorelin Acetate 9 mg multi-dose vials nationwide due to sub-potency. The affected lots do not contain the full intended strength of the medication.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a labeling/potency defect with no reported illnesses or injuries. The hazard is sub-potency (reduced drug strength), which is a quality issue rather than an acute safety threat. Per the severity rubric, Class II recalls without hospitalization reports or confirmed harm typically score 2 (Moderate).

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Sermorelin Acetate Lyophilized powder for reconstitution in multi-dose 9 mg vials (NDC 73198-0059-00) distributed nationwide in the USA including Puerto Rico.

The recall was initiated because the product was found to be sub-potent, meaning the vials did not contain the full therapeutic strength of the active ingredient. The affected lots are D44026 (Exp. 4/26/22) and F42104 (Exp. 6/4/22). A total of 2,283 vials are involved in the recall.

Sermorelin is a prescription medication. Patients should not stop taking their medication without first consulting their healthcare provider. Anyone with questions about whether their medication is affected should contact their pharmacist or doctor immediately.

This is a voluntary recall initiated by the manufacturing firm. The recall was classified by the FDA as Class II on March 29, 2022, and was terminated on October 4, 2023.

The recalled product

Product
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • sub-potent
  • reduced-efficacy

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)

  • Lots: D44026 Exp. 4/26/22
  • F42104 Exp. 6/4/22

Distribution

Distributed nationwide across the United States.

Related recalls

Same category