FDA Drug Recalls

October 17, 2014 · DrugView details →

Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.

Aurobindo Pharma USA Inc

Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Class ITerminated

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

Hospira Inc.

Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.

Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3

Apotex Inc.

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

Apotex Inc.

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

Pharmaceutical Associates Inc

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

Apotex Inc.

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3

Apotex Inc.

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Vann Healthcare Services Inc

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Vann Healthcare Services Inc

5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Vann Healthcare Services Inc

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.

Hospira Inc.

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Vann Healthcare Services Inc