Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFA, 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIBIMIX-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIST-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIST-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISB-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISB-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISB-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIT-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIT-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINB-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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIAT-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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIAT-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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula 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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIT-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 .
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISermorelin 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIDiluent 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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINAD+ 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
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugTeva Pharmaceuticals USA IncClass IILidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
cGMP Deviations
- 2022-05-04FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIZonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
cGMP deviations
- 2022-05-04FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIZonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
cGMP deviations
- 2022-05-04FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIZonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
cGMP deviations
- 2022-05-04FDA-DrugAmerican Health PackagingClass IIICyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59
Subpotent Drug: Out of specification for assay.
- 2022-05-04FDA-DrugPreferred Pharmaceuticals, Inc.Class IILosartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
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