FDA Recall
TerminatedTerminated: July 8, 2020Historical recordClass III
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass III
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
by Akorn Inc
- Reason
- Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.
by US Compounding Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- 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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