Drug and pharmaceutical recalls

17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-02-12FDA-DrugAscend Laboratories LLCClass III
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
2020-02-12FDA-DrugPD-Rx Pharmaceuticals, Inc.Class II
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
2020-02-12FDA-DrugSpectrum Laboratory ProductsClass II
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-02-05FDA-DrugPharmaceutical Associates IncClass II
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
Subpotent: Out of specification for assay at the 12-month time point.
2020-02-05FDA-DrugMacleods Pharma Usa IncClass III
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
2020-02-05FDA-DrugShandex Personal Care Manufacturing Inc.Class II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
2020-02-05FDA-DrugMcGuff Compounding Pharmacy Services, Inc.Class II
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Testosterone Topical Cream 4%
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
Tadalafil 6 mg Capsule
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
Tadalafil 20 mg Troche
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
T3/T4 SR 9 mcg/38 mcg capsule
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
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL
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
Sildenafil 80 mg capsules
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
Sildenafil 200 mg Troche (Clinic)
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
Progesterone E4M SR 100 mg capsules
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
Progesterone 50 mg capsules
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
Progesterone 200 mg Troche
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
Naltrexone 4.5 mg capsule
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
Magic Bullet Supplement
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
Liothyronine (T3) 92.5 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
Liothyronine (T3) 80 mcg SR cap
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
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
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
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
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
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.

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