Drug recall: Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP…
Class II FDA enforcement event 89717. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Sub Potent
Class II, in the words of FDA
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
Olympia Compounding Pharmacy dba Olympia Pharmacy started this drug recall on 8 Mar 2022. The firm address in the FDA record is in Orlando, FL. FDA put the recall in Class II. FDA event 89717 has 7 product records. The first FDA enforcement report date is 30 Mar 2022. The record gives the status Terminated, with the termination date 4 Oct 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA including Puerto Rico.
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy, Orlando, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0718-2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00 | 2283 vials | Class II | Terminated | 30 Mar 2022 |
| D-0719-2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando,… | 2634 vials | Class II | Terminated | 30 Mar 2022 |
| D-0720-2022 | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection… | 493 vials. | Class III | Terminated | 30 Mar 2022 |
| D-0721-2022 | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl… | 1093 vials | Class III | Terminated | 30 Mar 2022 |
| D-0722-2022 | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF,… | 1032 vials | Class III | Terminated | 30 Mar 2022 |
| D-0723-2022 | Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30 | 1613 vials | Class III | Terminated | 30 Mar 2022 |
| D-0724-2022 | Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia… | 836 vials | Class II | Terminated | 30 Mar 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2022
- 325
- Share of these events in Class II
- 65%
- Product records in this event
- 7Median of the firm: 34
- Events of the firm on the register
- 3
Other events of the firm
| 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 |
| 4 Apr 2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olymp | Drug | Class II | 34 |
Olympia Compounding Pharmacy dba Olympia Pharmacy: all 3 events
Official channels
- FDA enforcement report D-0718-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89717. https://recallregister.com/fda/ii/89717/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA including Puerto Rico.
- What quantity of product is in FDA event 89717?
- The event has 7 product records. The first record gives this quantity:
2283 vials
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2022 have the same class?
- 65% of the 325 drug events that started in 2022 are in Class II.