FDA Recall
Terminated
Historical recordClass I
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
by QuVa Pharma, Inc.
- Reason
- Subpotent Drug: Product may not have the active ingredient present in the bag.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
by ACCORD HEALTHCARE, INC.
- Reason
- Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
by Par Pharmaceutical, Inc.
- Reason
- Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
by Avkare Incorporated
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
by Avkare Incorporated
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
by Avkare Incorporated
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
by Avkare Incorporated
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
by Avkare Incorporated
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
by MCKESSON CORPORATION
- Reason
- Supterpotent Drug
- Published
- September 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorpated
- Product
- McDonalds Salad Ingredients, 9.25 lb, Salad Blend Romaine, C…
- Reason
- Fresh Express initiates a recall of expired foodservice salad products produced at its Streamwood, IL facility after a test yielded a positive result for the Cyclospora organism.
- Published
- September 12, 2018
- Distribution
- Domestic: IA, IL, IN, KY, MI, MN, MO, MT…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorpated
- Product
- McDonald s Whole Green Leaf Salad 1 lb
- Reason
- Fresh Express initiates a recall of expired foodservice salad products produced at its Streamwood, IL facility after a test yielded a positive result for the Cyclospora organism.
- Published
- September 12, 2018
- Distribution
- Domestic: IA, IL, IN, KY, MI, MN, MO, MT…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorpated
- Product
- Fresh Express Chopped Romaine 1 lb
- Reason
- Fresh Express initiates a recall of expired foodservice salad products produced at its Streamwood, IL facility after a test yielded a positive result for the Cyclospora organism.
- Published
- September 12, 2018
- Distribution
- Domestic: IA, IL, IN, KY, MI, MN, MO, MT…
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.
Read the full medical disclaimer.