Class I · High risk Terminated
NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals…
Reason Superpotent Drug.
Is Alpha recalled?
54 FDA recalls mention Alpha. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alpha.
Class I · High risk Terminated
NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC…
Reason Superpotent Drug.
Class I · High risk Terminated
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals…
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
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…
Reason Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class III · Low risk Terminated
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral…
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral…
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by…
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by…
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class I · High risk Terminated
ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6…
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk Terminated
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy…
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and…
Class II · Moderate risk Terminated
ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding…
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 2%), Rx…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class III · Low risk Terminated
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk Terminated
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Class II · Moderate risk Terminated
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Class II · Moderate risk Terminated
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg…
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class I · High risk Terminated
7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked…
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic…
Class I · High risk Terminated
M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured…
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic…
Class II · Moderate risk Terminated
Alpha Chymotrypsin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon…
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Class II · Moderate risk Terminated
D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348041010
Reason Labeling: Label Mixup; D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC…
Class II · Moderate risk Terminated
Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
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