FDA Recall
Terminated
Historical recordClass II
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
by Northern VA Compounders PLLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
by Northern VA Compounders PLLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
by Northern VA Compounders PLLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
by Northern VA Compounders PLLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
by Northern VA Compounders PLLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz.…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Dark Chocolate Peppermint Sea Salt Caramel: UPC 0-35…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Milk Chocolate Sea Salt Caramels: UPC 0-35900-27636-…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Assorted Milk and Dark Sea Salt Caramels UPC 0-35900…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sanders Candy LLC dba Second Nature Brands
- Product
- Sanders Dark Chocolate Sea Salt Caramels: UPC 0-35900-26442-…
- Reason
- Foreign material in product. Pieces of cleaning brush bristles found in the product
- Published
- January 18, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
by Pine Pharmaceuticals, LLC
- Reason
- CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
by Pfizer Inc.
- Reason
- Lack of assurance of sterility: Bags have the potential to leak.
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
by Eugia US LLC
- Reason
- Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cranberry Sweets & More Inc
- Product
- Recalled Meltaways product is packaged in clear cellophane b…
- Reason
- Peanut Butter Meltaway was mis-labeled as Mint Meltaways and peanut is undeclared.
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
by Apotex Corp.
- Reason
- Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
- Published
- January 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
by NCH Life Sciences LLC
- Reason
- CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
- Published
- January 4, 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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