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Showing 12341–12360 of 14370 results

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Mavik Trandolapril (AbbVie) – Outdated Package Insert (2013)

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

FDAAug 1, 2013Nationwide• AbbVie Inc.

Bupropion XL Tablets (Actavis) – Dissolution Failure (2013)

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

FDAJul 31, 2013Nationwide• Actavis Inc

Multi-Mineral Capsules (Purity First) – Undeclared Steroids (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.

Class IHigh

FDAJul 31, 2013CT, IN, NJ +1 more• Healthy Life Chemistry Inc dba Purity First

B-50 Capsules (Purity First) – Undeclared Steroids (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.

FDAJul 31, 2013CT, IN, NJ +1 more• Healthy Life Chemistry Inc dba Purity First

Belladonna Alkaloids Tablets (West-Ward) – Foreign Substance (2013)

Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

Class IIModerate

FDAJul 30, 2013Nationwide• West-Ward Pharmaceutical Corp.

Lisinopril Tablets (West-Ward) – Impurity Specification (2013)

Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

Class IIModerate

FDAJul 30, 2013Nationwide• West-Ward Pharmaceutical Corp.

Calcium EDTA (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Prog/Test CYP (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Dexamethasone Sodium Phosphate (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

MIC-Carn + B6/B12/Lidocaine Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Hydroxyprogesterone Caproate Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Dextrose PF 50% Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Estradiol Valerate Injectable (Beacon Hill) – Sterility Problem (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Glutathione (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Glutathione/Lidocaine (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Zinc Sulfate Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Furosemide Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Glycyrrhizic Acid (Beacon Hill) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

Procaine Injectable (Beacon Hill) – Sterility Problem (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

MIC-Carn Max Injectable (Beacon Hill Medical) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAJul 26, 2013Nationwide• Beacon Hill Medical Pharmacy, P.C.

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