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.

1–25 of 34

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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HighFDA (Drugs)··2022-05-04
T-105 Injectable Drug Recalled for Manufacturing Practice Deviations
Olympia Compounding Pharmacy is recalling T-105 injectables nationwide due to manufacturing process deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.
Product
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…
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HighFDA (Drugs)··2022-05-04
NAD+ Compounded Drug Recall for Manufacturing Quality Control Violations
Olympia Compounding Pharmacy is recalling NAD+ lyophilized powder (16,329 vials nationwide) due to failure to properly investigate environmental and personnel monitoring violations in manufacturing.
Product
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
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ModerateFDA (Drugs)··2022-05-04
Testosterone Cypionate Recalled Due to Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL due to failure to properly investigate manufacturing process monitoring deviations that occurred before October 2021. The recall affects 7,161 vials distributed nationwide.
Product
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.
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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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HighFDA (Drugs)··2022-05-04
Compounded ST-2 pharmaceutical vials recalled for manufacturing process deviations
Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical, nationwide due to manufacturing practice deviations and failures to properly investigate environmental and personnel monitoring excursions.
Product
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.
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HighFDA (Drugs)··2022-05-04
FDA Recalls Hydroxocobalamin B12 Injection for Manufacturing Control Failures
Olympia Compounding Pharmacy recalls 6,431 vials of Hydroxocobalamin B12 injection nationwide due to manufacturing quality control failures. Environmental and personnel monitoring systems prior to October 2021 did not properly investigate deviations from acceptable limits.
Product
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.
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HighFDA (Drugs)··2022-05-04
Injectable Drug SB-6 Recalled for Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy recalls SB-6 injectable drug due to manufacturing deficiencies. Prior to October 2021, environmental and personnel monitoring procedures were not properly investigated.
Product
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.
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ModerateFDA (Drugs)··2022-05-04
Alprostadil Injectable Drug Recalled for Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling 460 vials of Alprostadil 80 mcg/mL due to manufacturing quality control deviations related to improper investigation of environmental and personnel monitoring excursions prior to October 2021.
Product
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.
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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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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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HighFDA (Drugs)··2022-05-04
FDA Recalls Compounded Injectable Medication RE-2 Due to Manufacturing Deviations
Olympia Compounding Pharmacy is recalling 2,201 vials of RE-2, a compounded injectable medication, because environmental and personnel monitoring deviations were not properly investigated prior to October 2021.
Product
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.
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HighFDA (Drugs)··2022-05-04
Compounded Injectable Drug Recalled for Manufacturing Control Failures
Olympia Compounding Pharmacy is recalling NB-243, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.
Product
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
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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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HighFDA (Drugs)··2022-05-04
Compounded injectable drug recalled for manufacturing monitoring deviations
Olympia Compounding Pharmacy is recalling 388 vials of BIMIX-3 injection due to manufacturing process failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021, raising concerns about product quality.
Product
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.
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HighFDA (Drugs)··2022-05-04
Compounded Injection Recalled Due to Manufacturing Process Monitoring Deviations
Olympia Compounding Pharmacy recalled Formula F2 injectable (257 vials) due to improper investigation of manufacturing monitoring excursions before October 1, 2021. The product was distributed nationwide.
Product
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.
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HighFDA (Drugs)··2022-05-04
Compounded injectable drug recall for manufacturing process monitoring deviations
Olympia Compounding Pharmacy recalls 1110 vials of SB-5 injectable (nationwide) due to failure to properly investigate environmental monitoring deviations prior to October 2021. No illnesses reported.
Product
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.
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HighFDA (Drugs)··2022-05-04
Olympia Compounding Pharmacy Recalls AT-6 Injectable Drug Due to Manufacturing Control Deviations
Olympia Compounding Pharmacy is recalling AT-6 injectable drug due to manufacturing facility control failures. Environmental and personnel monitoring deviations were not properly investigated prior to October 2021.
Product
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
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ModerateFDA (Drugs)··2022-05-04
PGE-1 Alprostadil Injection Recalled for Manufacturing Process Deviations
Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.
Product
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.
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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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HighFDA (Drugs)··2022-05-04
Compounded injectable drug recall due to manufacturing quality control deviations
Olympia Compounding Pharmacy is recalling T-101, an injectable medication distributed nationwide, due to manufacturing quality control deviations in environmental and personnel monitoring prior to October 2021.
Product
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.
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HighFDA (Drugs)··2022-05-04
Alprostadil Injection Recalled Over Manufacturing Quality Control Failures
Olympia Compounding Pharmacy recalled PGE-3 Alprostadil 150 mcg/mL injection due to manufacturing facility failure to properly investigate environmental and personnel monitoring excursions.
Product
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.
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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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ModerateFDA (Drugs)··2022-05-04
Sincalide Injectable Vials Recalled for Manufacturing Monitoring Failures
Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide due to CGMP deviations in environmental and personnel monitoring. The manufacturer failed to properly investigate monitoring excursions prior to October 2021.
Product
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.
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HighFDA (Drugs)··2022-05-04
Prescription Injectable ST-1 Recalled for Manufacturing Process Control Failures
Olympia Compounding Pharmacy is recalling 525 vials of ST-1, a prescription injectable medication, due to manufacturing control failures.
Product
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.
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