FDA Recall
Terminated
Historical recordClass II
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
by Spirit Pharmaceuticals
- Reason
- cGMP deviations: Discolored acetaminophen
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
by DuPont Nutrition USA, Inc
- Reason
- Out of specification results for conductivity.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
by High Performance Formulas, L.L.C. (HPF, L.L.C.)
- Reason
- Marketed Without an Approved NDA/ANDA
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
by Novel Laboratories, Inc. d.b.a LUPIN
- Reason
- Failed Stability Specification; Out of specification for Osmolarity
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
by Aurobindo Pharma USA Inc.
- Reason
- Presence of Foreign Substance- Potential of metal contamination.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
by Med Shop Total Care Inc.
- Reason
- Non-Sterility
- Published
- August 18, 2021
- Distribution
- Texas and Puerto Rico
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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