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Showing 5061–5080 of 14370 results

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iSolutions Nano Tears (Altaire) – Sterility Problem (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Perrigo Sulfacetamide Ointment (Altaire) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Nano Tears MXP Forte Gel Drops (Altaire) – sterility concerns (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Puralube Petrolatum Ophthalmic Ointment (Altaire) – sterility concerns (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Equate Sterile Lubricant Stye Ointment (Altaire) – sterility concerns (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

CVS Health Lubricant Eye Ointment (Altaire) – sterility concerns (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Nano Tears TF Gel Drops (Altaire) – sterility problem (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Altaire Diclofenac Sodium Solution (Altaire) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

CVS Health Overnight Eye Ointment (Altaire) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Altaire Sterile Eye Wash (Altaire) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Accutome Rx Accu-WASH (Altaire) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Kaitlib Fe Chewable Tablets (Lupin) – impurity specification failure (2019)

Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.

Class IIModerate

FDAJul 2, 2019Nationwide• Lupin Pharmaceuticals Inc.

Nano Tears MXP Forte Lubricant Drops (iSolutions) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

iSolutions ActivEyes Nighttime Eye Ointment (Altaire) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Neo-Polycin HC Sterile Ointment (Altaire) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Walgreens Sodium Chloride Eye Ointment (Altaire) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

ActivEyes Altachlore Sodium Chloride Ointment (Altaire) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Walgreen's Lubricant Eye Ointment (Altaire) – sterility risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

OCuSOFT Retaine NaCl Ointment (Altaire) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

Perrigo Bacitracin Ophthalmic Ointment (Altaire) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 2, 2019Nationwide• Altaire Pharmaceuticals, Inc.

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