Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Finasteride/Biotin 1 mg/50 mcg
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
DHEA/Pregnenol One 10.25 MG Cap
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-01-29FDA-DrugHikma Pharmaceuticals USA Inc.Class III
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.
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.
2020-01-29FDA-DrugTuscano and Delucia Group (DBA Entropic Labs)Class II
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
2020-01-29FDA-DrugAdvanced Accelerator Applications USA, Inc.Class II
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.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
2020-01-29FDA-DrugRemedyRepack Inc.Class II
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
2020-01-29FDA-DrugPreferred Pharmaceuticals, IncClass II
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)
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-29FDA-DrugPreferred Pharmaceuticals, IncClass II
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-29FDA-DrugDenton Pharma, Inc.Class II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-29FDA-DrugDenton Pharma, Inc.Class II
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-29FDA-DrugH J Harkins Company Inc dba Pharma PacClass II
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-29FDA-DrugMylan Pharmaceuticals Inc.Class II
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
2020-01-29FDA-DrugMylan Pharmaceuticals Inc.Class II
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
2020-01-22FDA-DrugHikma Pharmaceuticals USA Inc.Class I
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
2020-01-22FDA-DrugMcGuff Compounding Pharmacy Services, Inc.Class II
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
2020-01-22FDA-DrugLupin Pharmaceuticals Inc.Class III
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
2020-01-22FDA-DrugAuroMedics Pharma LLCClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
2020-01-22FDA-DrugSun Pharmaceutical Industries, Inc.Class II
Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
2020-01-22FDA-DrugSun Pharmaceutical Industries, Inc.Class II
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
2020-01-22FDA-DrugSigan Industries Inc.Class III
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Microbial contamination of non-sterile product.
2020-01-22FDA-DrugWisconsin Pharmacal Company, LLCClass II
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
cGMP violations
2020-01-22FDA-DrugLetco Medical LLCClass II
Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
Subpotent
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Lack of sterility assurance.

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