The Recall Desk
HighFDA (Drugs)·D-0797-2022·Announced 2022-05-04

Sermorelin Acetate Vials Recalled for Manufacturing Quality Control Deviations

Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as a Class II recall due to manufacturing quality control deviations involving failure to properly investigate environmental and personnel monitoring excursions. While no illnesses or injuries have been reported, the systematic failure to investigate monitoring limits represents a risk-of-harm scenario affecting product quality and safety.

Plain-English summary

Olympia Compounding Pharmacy is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide in the United States. The recalled product is Sermorelin Acetate lyophilized powder for reconstitution in multi-dose vials, available in 3 mg (NDC 73198-0060-00) and 9 mg (NDC 73198-0059-00) strengths under Olympia Pharmaceuticals.

The recall is due to manufacturing quality control deviations. Prior to October 1, 2021, the manufacturing facility failed to properly investigate instances where environmental and personnel monitoring exceeded action limits (Out of Action Limit excursions). This represents a failure in manufacturing practices that could compromise product quality or safety.

Multiple lots are affected with beyond-use dates ranging through September 2022. Patients currently using this product should contact their healthcare provider or pharmacist for guidance about their specific lot number and appropriate next steps.

Patients should not use recalled vials without consulting their healthcare provider. The U.S. Food and Drug Administration is supervising this Class II recall.

The recalled product

Product
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug
Hazard
  • cgmp-deviation
  • quality-control-failure

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 (12)

  • Lots: a) D41019 BUD: 4/19/2022
  • b) D41112 BUD: 4/12/2022
  • D47028 BUD: 4/28/2022
  • F24009 BUD 3/4/2022
  • F41001 BUD: 6/1/2022
  • G48006 BUD: 7/14/2022
  • G48008 BUD: 7/8/2022
  • G48012 BUD: 7/12/2022
  • G48014 BUD: 7/14/2022
  • G48019 BUD: 7/9/2022
  • I24009 BUD: 9/9/2022
  • I41107 BUD: 9/7/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category