Home / Recalls / Olympia Compounding Pharmacy dba Olympia Pharmacy / D-0813-2022

D-0813-2022 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
1849 vials

Product Description

RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy 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) E47B18 BUD: 5/18/2022; b) E47C18 BUD: 5/18/2022, H24G31 BUD: 8/31/2022

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)