Food, drugs, devices › Olympia Compounding Pharmacy dba Olympia Pharmacy
Drug recall: NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olymp
Olympia Compounding Pharmacy dba Olympia Pharmacy (Orlando, FL) initiated this drug recall on 4 Apr 2022; FDA lists 34 product records under event 89938, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 17 Jun 2024. Initiation: voluntary: firm initiated. Olympia Compounding Pharmacy dba Olympia Pharmacy has 3 enforcement events on this register, with a median of 34 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy, Orlando, FL.
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
"Distributed Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0795-2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00 | 16,329 vials | Class II | Terminated | 4 May 2022 |
| D-0796-2022 | Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10 | 45,935 vials | Class II | Terminated | 4 May 2022 |
| D-0797-2022 | 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. | 18060 vials | Class II | Terminated | 4 May 2022 |
| D-0798-2022 | QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10. | 1871 vials | Class II | Terminated | 4 May 2022 |
| D-0799-2022 | T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 . | 6916 vials | Class II | Terminated | 4 May 2022 |
| D-0800-2022 | Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10 | 800 vials | Class II | Terminated | 4 May 2022 |
| D-0801-2022 | AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10 | 1318 vials | Class II | Terminated | 4 May 2022 |
| D-0802-2022 | AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10 | 310 vials | Class II | Terminated | 4 May 2022 |
| D-0803-2022 | NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10 | 3509 vials | Class II | Terminated | 4 May 2022 |
| D-0804-2022 | T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC: 73198-0013-10; b) 5 mL Multi-Dose vial, NDC 73198-0013-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | 4129 vials | Class II | Terminated | 4 May 2022 |
| D-0805-2022 | 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. | 2437 vials | Class II | Terminated | 4 May 2022 |
| D-0806-2022 | SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10. | 1740 vials | Class II | Terminated | 4 May 2022 |
| D-0807-2022 | SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10. | 1110 vials | Class II | Terminated | 4 May 2022 |
| D-0808-2022 | SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10. | 336 vials | Class II | Terminated | 4 May 2022 |
| D-0809-2022 | ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10. | 525 vials | Class II | Terminated | 4 May 2022 |
| D-0810-2022 | ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10. | 2005 vials | Class II | Terminated | 4 May 2022 |
| D-0811-2022 | QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10. | 1679 vials | Class II | Terminated | 4 May 2022 |
| D-0812-2022 | QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10. | 1647 vials | Class II | Terminated | 4 May 2022 |
| D-0813-2022 | 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. | 1849 vials | Class II | Terminated | 4 May 2022 |
| D-0814-2022 | RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10. | 2201 vials | Class II | Terminated | 4 May 2022 |
| D-0815-2022 | BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10. | 388 vials | Class II | Terminated | 4 May 2022 |
| D-0816-2022 | FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10. | 2887 vials | Class II | Terminated | 4 May 2022 |
| D-0817-2022 | PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10. | 821 vials | Class II | Terminated | 4 May 2022 |
| D-0818-2022 | PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10. | 460 vials | Class II | Terminated | 4 May 2022 |
| D-0819-2022 | PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10. | 410 vials | Class II | Terminated | 4 May 2022 |
| D-0820-2022 | T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10. | 1097 vials | Class II | Terminated | 4 May 2022 |
| D-0821-2022 | Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10. | 257 vials | Class II | Terminated | 4 May 2022 |
| D-0822-2022 | Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05. | 4521 vials | Class II | Terminated | 4 May 2022 |
| D-0823-2022 | Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | 7161 vials | Class II | Terminated | 4 May 2022 |
| D-0824-2022 | Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | 3962 vials | Class II | Terminated | 4 May 2022 |
| D-0825-2022 | Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10. | 1276 vials | Class II | Terminated | 4 May 2022 |
| D-0826-2022 | Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30. | 6431 vials | Class II | Terminated | 4 May 2022 |
| D-0827-2022 | Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00. | 1770 vials | Class II | Terminated | 4 May 2022 |
| D-0828-2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00 | — | Class II | Terminated | 4 May 2022 |
Context
Other enforcement events for Olympia Compounding Pharmacy dba Olympia Pharmacy
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 May 2022 | QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, | Drug | Class II | 53 |
| 8 Mar 2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, S | Drug | Class II | 7 |
All 3 events for Olympia Compounding Pharmacy dba Olympia Pharmacy
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Jun 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.