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Showing 901–920 of 1310 results

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Vitamin B-Complex Preservative Free (Tailor Made) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2022Nationwide• TMC Acquisition LLC dba Tailor Made Compounding

Teriparatide (Tailor Made Compounding) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2022Nationwide• TMC Acquisition LLC dba Tailor Made Compounding

Methylphenidate Chewable Tablets (Rising) – Tablet Specification Issue (2022)

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

Class IIModerate

FDAFeb 7, 2022Nationwide• RISING PHARMACEUTICALS

Lexette Topical Foam (Mayne Pharma) – Dispensing Issue (2022)

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Class IIModerate

FDAJan 14, 2022Nationwide• Mayne Pharma Inc

Medroxyprogesterone Injection (Ideal Pharmacy) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 21, 2021Nationwide• Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy

Lidocaine Hydrochloride Solution (Teligent) - Superpotent Drug (2021)

Superpotent Drug: Minimally superpotent

Class IIModerate

FDANov 30, 2021Nationwide• Teligent Pharma, Inc.

Diclofenac Sodium Solution (Preferred) - Container Defect (2021)

Defective container: Out of specification for container integrity leading to bottles leaking.

Class IIModerate

FDANov 29, 2021CT, FL, IN +1 more• Preferred Pharmaceuticals, Inc.

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix 0.5mg/1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix 1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Combipatch 0.05/0.14mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Combipatch 0.05/0.25mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Erythromycin Topical Solution (Teligent) – Container Defect (2021)

Defective container: possibility for lack of seal integrity.

Class IIModerate

FDAJul 29, 2021Nationwide• Teligent Pharma, Inc.

Miss Slim Capsules (HIS Enterprise) – Unapproved Marketing (2021)

Marketed without ANDA/NDA approval

Class IIModerate

FDAJul 20, 2021Nationwide• HIS ENTERPRISE INC

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Daytrana 15mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 10mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

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