FDA Recall
Ongoing
Historical recordClass II
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
by Akorn, Inc.
- Reason
- CGMP Deviations:
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
by Akorn, Inc.
- Reason
- CGMP Deviations:
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
by ACCORD HEALTHCARE, INC.
- Reason
- Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ByHeart, INC.
- Product
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680…
- Reason
- Infant formula potentially contaminated with Cronobacter sakazakii
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Something South African LLC
- Product
- Pepper Collection 8 Tube Gift Set - a colorful assortment of…
- Reason
- Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.
- Published
- January 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/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
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 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 Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/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
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/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
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/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
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/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 Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 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
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 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
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/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
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 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
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 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
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 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 →
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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