Class I - Dangerous
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Pharmaceutical Associates
Class I - Dangerous
Subpotent: Out of specification for assay at the 12-month time point.
Tadalafil 6 mg Capsule
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Naltrexone 4.5 mg capsule
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Sildenafil 80 mg capsules
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Progesterone E4M SR 100 mg capsules
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
McGuff Compounding Pharmacy Services
Class I - Dangerous
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class I - Dangerous
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Progesterone 50 mg capsules
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
T3/T4 SR 9 mcg/38 mcg capsule
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
Tuscano and Delucia Group (DBA Entropic Labs)
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
Hikma Pharmaceuticals USA
Class I - Dangerous
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
RemedyRepack
Class I - Dangerous
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
Advanced Accelerator Applications USA
Class I - Dangerous
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.