🍔 Food 💊 Drugs 🏥 Medical Devices
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30 Class II

Reason: Subpotent drug: low fill volume in some of the capsules

Sanofi US 20130307 Terminated
Distributed: Nationwide
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MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30 Class II

Reason: Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

AstraZeneca Pharmaceuticals LP 20130621 Terminated
Distributed: USA and Puerto Rico
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VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06, Class II

Reason: Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

West-Ward Pharmaceutical Corp. 20130604 Terminated
Distributed: GA
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Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10 Class I

Reason: Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Zydus Pharmaceuticals USA Inc 20130513 Terminated
Distributed: Nationwide
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Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. Class I

Reason: Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.

Reumofan Plus USA 20130104 Terminated
Distributed: Nationwide through internet sales.
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0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. Class I

Reason: Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates

Hospira Inc. 20130329 Terminated
Distributed: Nationwide
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Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0 Class I

Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Apotex Corp. 20130510 Terminated
Distributed: Nationwide
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Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8). Class I

Reason: Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

Chang Kwung Products 20130506 Terminated
Distributed: Nationwide
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Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). Class I

Reason: Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

Chang Kwung Products 20130506 Terminated
Distributed: Nationwide
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Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01. Class I

Reason: Presence of Particulate Matter: Found during examination of retention samples.

Sandoz Incorporated 20130520 Terminated
Distributed: Nationwide
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