Class I · High risk Terminated
Phenylephrine HCl
Reason Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class I · High risk Terminated
puriton EYE RELIEF DROPS
Reason Non-Sterility: Product manufactured under non-sterile production conditions.
Class I · High risk Terminated
Levetiracetam in 0.54 % Sodium Chloride Injection 1
Reason Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Class I · High risk Terminated
Native Remedies EyeClear Pro Oral Spray
Reason Microbial Contamination of Non-Sterile Product
Class I · High risk Terminated
Native Remedies VaricoGo Oral Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
Native Remedies HypoSlim Oral Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
Native Remedies VertiFree Oral Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
robaxin-750
Reason Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class I · High risk Terminated
Norepinephrine 4 mg
Reason Subpotent Drug: Product may not have the active ingredient present in the bag.
Class I · High risk Terminated
Respitrol
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Thyroveev
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Neuroveen
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Compulsin
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Hydrochlorothiazide Tablets USP
Reason Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Class I · High risk Ongoing
Montelukast Sodium Tablets 10 mg
Reason Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Class I · High risk Terminated
Living Well Remedies Weight Away Remedy
Reason Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Sinus Relief
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.