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 I
Mojave Foods Corp.
- Product
- El Guapo Jamaica Hibiscus Flowers in flexible pouches , 1…
- Reason
- Mojave Foods Corporation has initiated a recall of its El Guapo Jamaica Hibiscus Flowers in flexible pouches (1 oz., 2 oz., 8 oz., 16 oz., 10 lb.) . UPC # 044989201911, UPC # 044989005229, UPC # 044989012890, UPC # 044989013347,UPC # 079466071985, because of undeclared allergen.
- Published
- September 12, 2018
- Distribution
- Product shipped predominantly to the Sou…
View recall →
FDA Recall
Terminated
Historical recordClass III
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
by Validus Pharmaceuticals, Inc.
- Reason
- Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
by Validus Pharmaceuticals, Inc.
- Reason
- Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
by Pfizer Global Supply
- Reason
- Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
- Published
- September 5, 2018
- 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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