Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155…
Reason Lack of assurance of sterility.
Is Tetradecyl recalled?
23 FDA recalls mention Tetradecyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tetradecyl.
Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc, JD & SN Inc, DBA Moses Lake Professional…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC…
Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated…
Class II · Moderate risk Terminated
Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
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 Ongoing
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate 5.0% 30ml, 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…
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate 3.0%, 30ml 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…
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate 2.0% 30ml, 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…
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc…
Reason Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc…
Reason Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b)…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Class II · Moderate risk Terminated
SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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