Home / Recalls / Olympia Compounding Pharmacy dba Olympia Pharmacy / D-0797-2022

D-0797-2022 Class II Terminated

Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
May 4, 2022
Initiation Date
April 4, 2022
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18060 vials

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

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

Other recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy

  • D-0926-2022 Class II — Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Oly (May 9, 2022)
  • D-0945-2022 Class II — Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6 (May 9, 2022)
  • D-0919-2022 Class II — AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 (May 9, 2022)
  • D-0937-2022 Class II — MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalam (May 9, 2022)
  • D-0916-2022 Class II — Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutica (May 9, 2022)
  • D-0923-2022 Class II — Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, (May 9, 2022)
  • D-0946-2022 Class II — Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutical (May 9, 2022)
  • D-0903-2022 Class II — Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica (May 9, 2022)
  • D-0934-2022 Class II — Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg (May 9, 2022)
  • D-0928-2022 Class II — Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropin (May 9, 2022)