FDA Recall
🇺🇸 United States
TerminatedTerminated: July 19, 2019Historical recordClass I
Air Stream Corp.
- Product
- Salad Mix (Green Kale, Green Cabbage, Broccoli Stems, Chicor…
- Reason
- The product may be contaminated with Listeria monocytogenes.
- Published
- September 19, 2018
- Distribution
- Massachusetts, New York, New Jersey, Con…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 2019Historical recordClass II
Dewey's Bakery, Inc dba Salem Baking Company
- Product
- Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES N…
- Reason
- The firm was notified by a customer that mold was in the product.
- Published
- September 19, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: November 25, 2020Historical 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
TerminatedTerminated: January 22, 2021Historical 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
TerminatedTerminated: January 22, 2021Historical 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
TerminatedTerminated: February 11, 2021Historical 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 →
FDA Recall
TerminatedTerminated: November 3, 2020Historical recordClass III
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 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.
Read the full medical disclaimer.