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.
Reported: May 4, 2022 Initiated: April 4, 2022 #D-0797-2022
Product Description
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.
Reason for Recall
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Details
- Recalling Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Units Affected
- 18060 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 18060 vials.
Why was this product recalled? ▼
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0797-2022.
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