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Showing 4741–4760 of 14370 results

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Phenylephrine Hydrochloride Ophthalmic Solution (Akorn) – Sterility Concern (2019)

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

Class IIModerate

FDASep 20, 2019Nationwide• Akorn, Inc.

Dextroamphetamine Mixed Salts (Aurobindo) – Superpotent Drug (2019)

Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.

Class IIModerate

FDASep 19, 2019Nationwide• Aurobindo Pharma USA Inc.

Losartan Potassium Tablets 50mg (Torrent) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Class IIModerate

FDASep 19, 2019Nationwide• Torrent Pharma Inc.

Losartan/Hydrochlorothiazide Tablets 100mg (Torrent) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Class IIModerate

FDASep 19, 2019Nationwide• Torrent Pharma Inc.

Losartan/Hydrochlorothiazide Tablets 50mg (Torrent) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Class IIModerate

FDASep 19, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets 100mg (Torrent) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Class IIModerate

FDASep 19, 2019Nationwide• Torrent Pharma Inc.

Infant's Gas Relief Drops (GCP) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Product.

Class IIModerate

FDASep 18, 2019Nationwide• GCP Laboratories Inc

Lidocaine Hydrochloride Jelly (Akorn) – Metal Particulate (2019)

cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.

Class IIModerate

FDASep 17, 2019Nationwide• Akorn, Inc.

Mero Macho Liquid Supplement (Fitoterapia) – Tadalafil Taint (2019)

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

FDASep 16, 2019FL, NY, PA• FITOTERAPIA USA, INC

Abbott Calcilo XD Infant Formula (Abbott) – seal defect (2019)

Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.

Class IIModerate

FDASep 13, 2019Nationwide• Abbott Laboratories

Sodium Chloride Injection (Guerbet) – RFID Labeling Issue (2019)

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

FDASep 13, 2019Nationwide• GUERBET LLC

Optiray 320 Injection (Guerbet) – RFID Labeling Issue (2019)

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

Class IIModerate

FDASep 13, 2019Nationwide• GUERBET LLC

Zarontin Ethosuximide Capsules (Pfizer) – incorrect labeling (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

FDASep 12, 2019Nationwide• Pfizer Inc.

L-Carnitine (KRS Global) – sterility risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

Ketamine IV Solution (KRS Global) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

Bimix #3 Injection (KRS Global) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

Hydroxocobalamin 10 mg/20 mL (KRS Global) – Sterility Issue (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

Vitamin 5 B Injection (KRS Global) – Sterility Problem (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

L-Asparaginase 10,000 Units (KRS Global) – Sterility Problem (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

Methylcobalamin 30 mg (KRS Global) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 12, 2019Nationwide• KRS Global Biotechnology, Inc

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