FDA Recall
Completed
Historical recordClass II
Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
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, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
by GlaxoSmithKline LLC
- Reason
- Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints exceeded respective action limits.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
by Direct Rx
- Reason
- CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Able Sales Company, Inc.
- Product
- Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelu…
- Reason
- Traces of 2-chloro-ethanol (2-CE) in wheat gluten.
- Published
- June 1, 2022
- Distribution
- Domestic distribution only - PR
View recall →
FDA Recall
Terminated
Historical recordClass III
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
by Apotex Corp.
- Reason
- Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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