Drug Recall
Terminated
Historical recordClass II
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
- Recall initiated
- November 12, 2015
- Reported by FDA
- January 20, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
by Amerisource Health Services
- Reason
- Presence of Particulate Matter
- Recall initiated
- October 29, 2015
- Reported by FDA
- January 20, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
by PQ Corporation
- Reason
- Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
- Recall initiated
- October 29, 2015
- Reported by FDA
- January 13, 2016
- Distribution
- Kentucky
View recall →
Drug Recall
Terminated
Historical recordClass III
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
by Avantor Performance Materials Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
- Recall initiated
- October 30, 2015
- Reported by FDA
- January 13, 2016
- Distribution
- Distributed in the US including: CA, IL & NC; Canada
View recall →
Drug Recall
Terminated
Historical recordClass II
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
by PD-Rx Pharmaceuticals, Inc.
- Reason
- cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- Recall initiated
- April 29, 2015
- Reported by FDA
- January 13, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
by PD-Rx Pharmaceuticals, Inc.
- Reason
- cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- Recall initiated
- April 29, 2015
- Reported by FDA
- January 13, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China
by Freedom Pharmaceuticals Inc
- Reason
- Subpotent Drug
- Recall initiated
- January 8, 2015
- Reported by FDA
- January 13, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
by PD-Rx Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- July 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Alabama
View recall →
Drug Recall
Terminated
Historical recordClass II
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
Drug Recall
Terminated
Historical recordClass II
IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
by Walgreens Infusion Services
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- November 10, 2015
- Reported by FDA
- January 6, 2016
- Distribution
- Texas
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
