FDA Recall
Terminated
Historical recordClass II
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
by Ferring Pharmaceuticals Inc
- Reason
- cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
by The Harvard Drug Group
- Reason
- Packaging defect: blister packaging inadequately sealed.
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Anatox Inc
- Product
- Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber…
- Reason
- Elevated lead levels
- Published
- July 5, 2023
- Distribution
- Distributors, retailers, and consumers i…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Anatox Inc
- Product
- 1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an ambe…
- Reason
- Elevated lead levels
- Published
- July 5, 2023
- Distribution
- Distributors, retailers, and consumers i…
View recall →
FDA Recall
Terminated
Historical recordClass I
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
- Published
- June 28, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 28, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ENTRINSIC HEALTH SOLUTION INC
- Product
- enterade Advanced Oncology Formula; Original Vanilla Flavor;…
- Reason
- Potential for the product to develop mold and spoil.
- Published
- June 28, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nutricia North America
- Product
- TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g)…
- Reason
- Infant formula contains undeclared tyrosine
- Published
- June 28, 2023
- Distribution
- Alaska, California, Connecticut, Florida…
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
by AVKARE LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- Chemical Contamination: FDA testing found Presence of methanol
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- Chemical Contamination: FDA testing found Presence of methanol
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
by Amring Pharmaceuticals Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
HU PRODUCTS
- Product
- Hu Vanilla Crunch Dark Chocolate bar
- Reason
- may contain undeclared tree-nuts
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations
- Published
- June 14, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
by Golden State Medical Supply Inc.
- Reason
- Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
- Published
- June 14, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
by Empower Clinic Services LLC dba Empower Pharmacy
- Reason
- Mislabeling: preservative free product labeled as preserved.
- Published
- June 14, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- 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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