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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 17381–17400 of 17,860 recalls

Class IITerminated

All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

New England Compounding Center

Lack of Assurance of Sterility

October 6, 2012 · DrugView details →

Class IITerminated

All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

New England Compounding Center

GMP Deviations

October 6, 2012 · DrugView details →

Class ITerminated

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

Hospira Inc.

Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.

October 5, 2012 · DrugView details →

Class IITerminated

Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.

Earthborn Products, Inc.

Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.

October 5, 2012 · DrugView details →

Class IITerminated

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

Hospira, Inc.

Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.

October 4, 2012 · DrugView details →

Class IITerminated

Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,

Paddock Laboratories, LLC

Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.

October 3, 2012 · DrugView details →

Class IIITerminated

Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9.

ITW Dymon

CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.

September 28, 2012 · DrugView details →

Class IITerminated

CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.

Fresenius Kabi USA, LLC

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

September 27, 2012 · DrugView details →

Class IITerminated

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

Fresenius Kabi USA, LLC

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

September 27, 2012 · DrugView details →

Class IIITerminated

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.

Genentech, Inc.

Short Fill: some bottles contained less than 120-count per labeled claim.

September 27, 2012 · DrugView details →

Class IITerminated

Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05

Dr. Reddy's Laboratories, Inc.

Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

September 27, 2012 · DrugView details →

Class IITerminated

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

Fresenius Kabi USA, LLC

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

September 27, 2012 · DrugView details →

Class ITerminated

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Non-Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class ITerminated

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Non-Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

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