Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

Class IIModerate

FDAAug 3, 2016CA• Aurobindo Pharma USA Inc

Venlafaxine Extended-Release Capsules (Golden State Medical) – Dissolution Specification Failure ...

Failed Dissolution Specifications: Out-of-specification results in retained sample.

Class IIModerate

FDAAug 3, 2016Nationwide• Golden State Medical Supply Inc.

Venlafaxine Extended-Release Capsules (Golden State Medical) – Dissolution Specification Failure ...

Failed Dissolution Specifications: Out-of-specification results in retained sample.

Class IIModerate

FDAAug 3, 2016Nationwide• Golden State Medical Supply Inc.

Hydrocortisone Acetic Acid Solution (Actavis) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

Class IIILow

FDAAug 2, 2016Nationwide• Actavis Inc

Acetasol HC Otic Solution (Actavis) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

Class IIILow

FDAAug 2, 2016Nationwide• Actavis Inc

Dietary Supplement (Life Rising) – Lead Contamination (2016)

The dietary supplement contains lead.

Class IHigh

FDAAug 1, 2016AR, CA, CO +6 more• Life Rising Corp S

Betamethasone Acetate Injection (Isomeric Pharmacy) – Processing Control Issue (2016)

Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.

Class IIModerate

FDAAug 1, 2016Nationwide• Isomeric Pharmacy Solution, LLC

Amikacin Sulfate Injection (Teva) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJul 29, 2016Nationwide• Teva Pharmaceuticals USA

Amikacin Sulfate Injection (Teva) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJul 29, 2016Nationwide• Teva Pharmaceuticals USA

C-PAV/PHENTOL/ATROP/PGE1 (Colonia Care) – Sterility Concern (2016)

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

Class IIModerate

FDAJul 28, 2016NJ, NY• Colonia Care Pharmacy

C-PAV/PHENTOL/PGE1 (Colonia Care) – Sterility Concern (2016)

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

Class IIModerate

FDAJul 28, 2016NJ, NY• Colonia Care Pharmacy

Zolpidem Tartrate (Novel Labs) – Child Safety Issue (2016)

This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches.

CPSCJul 27, 2016Nationwide• Novel Laboratories, of Somerset, N.J.

Desoximetasone Gel (Akorn) – Impurity Specification Fail (2016)

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Class IIILow

FDAJul 27, 2016Nationwide• Akorn, Inc.

Papaverine/Phentolamine Vials (Vital Care Compounder) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 26, 2016MS• Pharmacy Plus, Inc. dba Vital Care Compounder

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