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Showing 8081–8100 of 15081 results

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VI PEEL (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

REVERSE DML LOTION (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

TRICHLOROACETIC ACID SOLUTION (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

KOJIC AZELAIC ACID CREAM (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Human Chorionic Gonadotropin (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Fluocinonide 0.05% Solution (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

AZELAIC ACID 15% CREAM (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

LTP Topical Cream (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Ibuprofen Lysine Injection (X-Gen) – Particulate Matter (2017)

Presence of Particulate Matter

FDAFeb 8, 2017Nationwide• X-Gen Pharmaceuticals Inc.

CycloSPORINE Capsules (Amerisource) – Impurity Specifications (2017)

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities

Class IIModerate

FDAFeb 8, 2017Nationwide• Amerisource Health Services

Xanthium & Siler Combo (Kingsway) – Banned ephedra (2017)

Presence of Ephedrae Herba (ma huang), a FDA Banned Ephedra Alkaloid

FDAFeb 7, 2017AZ, CO, CT +14 more• Kingsway Trading Inc

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 7, 2017Nationwide• Teva Pharmaceuticals USA

Indocin Suppositories (G&W) – Impurity Specifications (2017)

Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.

Class IIModerate

FDAFeb 7, 2017Nationwide• G & W Laboratories, Inc.

Levofloxacin Ophthalmic Solution (Actavis) – Impurity Concerns (2017)

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

FDAFeb 7, 2017Nationwide• Actavis Inc

Vancomycin HCl Dextrose IV Bag (SCA Pharmaceuticals) – particulate matter (2017)

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

FDAFeb 3, 2017Nationwide• SCA Pharmaceuticals

Vancomycin HCl IV Bag (SCA Pharmaceuticals) – particulate matter (2017)

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

FDAFeb 3, 2017Nationwide• SCA Pharmaceuticals

Vancomycin HCl Dextrose IV Bag (SCA Pharmaceuticals) – particulate matter (2017)

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

FDAFeb 3, 2017Nationwide• SCA Pharmaceuticals

GlipiZIDE Extended-Release Tablets (Amerisource) – dissolution failure (2017)

Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Class IIModerate

FDAFeb 3, 2017Nationwide• Amerisource Health Services

Vancomycin HCl Sodium Chloride IV Bag (SCA Pharmaceuticals) – particulate matter (2017)

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

FDAFeb 3, 2017Nationwide• SCA Pharmaceuticals

Vancomycin HCl Sodium Chloride IV Bag (SCA Pharmaceuticals) – particulate matter (2017)

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

FDAFeb 3, 2017Nationwide• SCA Pharmaceuticals

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