Class II · Moderate risk Ongoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1…
Reason Lack of Assurance of Sterility
Is Cotton recalled?
14 FDA recalls mention Cotton. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cotton.
Class III · Low risk Terminated
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box…
Reason Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box…
Class II · Moderate risk Terminated
C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class III · Low risk Terminated
DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class II · Moderate risk Terminated
Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL)…
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk Terminated
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor…
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk Terminated
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness…
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
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin…
Reason Chemical contamination: Product may be contaminated with a toxic compound.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class III · Low risk Terminated
I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New…
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk Terminated
TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054…
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class II · Moderate risk Terminated
Oral B-12 30ml--cotton candy, 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
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS…
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 because…
Class II · Moderate risk Terminated
PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME…
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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