Class II · Moderate risk
Trelstar (triptorelin pamoate)
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class II · Moderate risk
0.45% Sodium Chloride Injection USP
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Class II · Moderate risk
Pantaprazole Sodium Delayed Release Tablets
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Class II · Moderate risk
Niacin Extended Release Tablets
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class II · Moderate risk
Dollar General Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
Dr. Sheffield Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class I · High risk
Hyperlyte CR
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
ProcalAmine
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
TrophAmine
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
15% Amino Acids Injection PBP Glass
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
6.9% FreAmine HBC
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
0.9 % Sodium Chloride Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefazolin for Injection USP and Dextrose Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefazolin for Injection USP and Dextrose Injections USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefepime for Injections USP and Dextrose Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Ceftriaxone for Injection and Dextrose Injection
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefoxitin for Injection and Dextrose Injection
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Class I · High risk
5% Dextrose Injection
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag