FDA Recall
Terminated
Historical recordClass I
Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA
by Central Admixture Pharmacy Services, Inc.
- Reason
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
by Hospira Inc.
- Reason
- Crystallization
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
by Hospira Inc.
- Reason
- Crystallization
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.
by Heritage Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
by Hospira Inc.
- Reason
- Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
by Navinta LLC
- Reason
- Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.
by Qualitest Pharmaceuticals
- Reason
- Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
- Published
- April 15, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
by American Health Packaging
- Reason
- Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
- Published
- April 8, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
by Baxter Healthcare Corp
- Reason
- Lack of Assurance of Sterility; increased complaints received for leaks
- Published
- April 8, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
by Baxter Healthcare Corp
- Reason
- Lack of Assurance of Sterility; increased complaints received for leaks
- Published
- April 8, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
- Published
- April 1, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
- Published
- April 1, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
by Bethel Nutritional Consulting, Inc
- Reason
- Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
- Published
- April 1, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
by Mylan Institutional LLC
- Reason
- Lack of Assurance of Sterility; due to leaking vials
- Published
- April 1, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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