Home / Recalls / Olympia Compounding Pharmacy dba Olympia Pharmacy / D-0805-2022

D-0805-2022 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
2437 vials

Product Description

T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; 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) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022

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)