FDA (Drugs) recall action 89938

Olympia Compounding Pharmacy dba Olympia Pharmacy recalled 34 products on 2022-05-04

The FDA (Drugs) publishes a recall like this one as 34 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 34 pages.

Products: 34
Announced: 2022-05-04
Critical: 0
Units: 146,147

Why these products were recalled

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Failed Reconstitution time

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–34 of 34

HighFDA (Drugs)··2022-05-04
Compounding Pharmacy Recalls Injectable Medication Vials for Manufacturing Quality Failures
Olympia Compounding Pharmacy recalls 1,871 multi-dose vials of QM-2 injectable medication due to failure to properly investigate manufacturing monitoring excursions prior to October 2021. No illnesses reported.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
Compounded Injection Medication Recalled Due to Manufacturing Monitoring Deficiencies
Olympia Compounding Pharmacy recalls 1,679 vials of QM-3 injection medication nationwide due to failures in environmental and personnel monitoring during manufacturing.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
Phenylephrine Injectable Recalled Due to Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL due to manufacturing quality control failures. Environmental and personnel monitoring procedures were not properly investigated prior to October 1, 2021.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
T-106 Injectable Drug Recalled for Manufacturing Control Deviations
Olympia Compounding Pharmacy is recalling T-106 injectable drug nationwide (4,129 vials) due to manufacturing control deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
FDA Recalls Compounded Drug Due to Manufacturing Monitoring Deviations
Olympia Compounding Pharmacy is recalling SB-4 due to manufacturing quality control failures. The company did not properly investigate environmental and personnel monitoring problems that occurred before October 2021.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
Diluent for Reconstitution Recalled Due to Manufacturing Compliance Failures
Olympia Pharmacy has recalled 45,935 vials of pharmaceutical diluent due to manufacturing compliance deviations. Environmental and personnel monitoring limits were exceeded and not properly investigated prior to October 2021.
Product
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
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0 states
HighFDA (Drugs)··2022-05-04
QM-4 Compounded Injectable Recalled for Manufacturing Control Deviations
Olympia Compounding Pharmacy is recalling QM-4, a compounded injectable, for manufacturing control deviations. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
Compounded Injectable Drug Recalled Due to Manufacturing Process Violations
Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.
Product
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.
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0 states
HighFDA (Drugs)··2022-05-04
Sermorelin Acetate Vials Recalled for Manufacturing Quality Control Deviations
Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.
Product
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.
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0 states