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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3761–3780 of 17,755 recalls

Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · Drug
View details →
Class IITerminated

HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9

Hand Sanitizer LLC

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

April 4, 2022 · DrugView details →
Class IITerminated

BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a) 12OZ/355ML bottles, UPC 48558 94603 6 b) 5 Gallon/18,927ML pail C)1 Gallon/3,785ML jug; d)4OZ/118ML spray top bottles; Produced By; Beak & Skiff Farms Apple Farms Inc. Lafayette, NY 13084.

Beak & Skiff Cider Mill, Inc.

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

April 4, 2022 · FDAView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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

Olympia Compounding Pharmacy dba Olympia Pharmacy

Failed Reconstitution time

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IITerminated

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.

Olympia Compounding Pharmacy dba Olympia Pharmacy

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

April 4, 2022 · DrugView details →
Class IIITerminated

Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

April 1, 2022 · DrugView details →
Class IITerminated

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.

Mylan Pharmaceuticals Inc

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.

April 1, 2022 · DrugView details →
Class IITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

April 1, 2022 · DrugView details →
Class IIITerminated

23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0

The Ritedose Corporation

Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.

April 1, 2022 · DrugView details →
Class IIOngoing

CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx

Wellness BioSciences

Marketed Without an Approved NDA/ANDA

April 1, 2022 · DrugView details →
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