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
Terminated
Historical recordClass II
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
by Direct Rx
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Published
- June 1, 2022
- Distribution
- FL
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
by Direct Rx
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Published
- June 1, 2022
- Distribution
- FL
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
by Direct Rx
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Published
- June 1, 2022
- Distribution
- FL
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 1, 2022
- Distribution
- Within the U.S in FL and CA.
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 1, 2022
- Distribution
- Within the U.S in FL and CA.
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
Terminated
Historical recordClass II
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
by RemedyRePack Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Published
- June 1, 2022
- Distribution
- Product was distributed to FL, SC and VA
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
by RemedyRePack Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Published
- June 1, 2022
- Distribution
- Product was distributed to FL, SC and VA
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
by RemedyRePack Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 1, 2022
- Distribution
- Recalled product was distributed to Flor…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mrs Millers Homemade Jams LLC.
- Product
- Mrs. Miller's Homemade Jam Spicy Chili Bacon Jam packaged in…
- Reason
- Undeclared Allergen - Soy
- Published
- June 1, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mrs Millers Homemade Jams LLC.
- Product
- Mrs. Miller's Homemade Jam Smokey BBQ Bacon Jam packaged int…
- Reason
- Undeclared Allergen - Soy
- Published
- June 1, 2022
- Distribution
- Multiple states
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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