Class I - Dangerous
Superpotent drug: out of specification result for potency
💊
Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
Dr. Reddy's Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Ace Surgical Supply Co.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class I - Dangerous
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Class I - Dangerous
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class I - Dangerous
Lack Of Assurance Of Sterility.
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
SCA Pharmaceuticals
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Subpotent Drug: low out of specification results.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
SCA Pharmaceuticals
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class I - Dangerous
Lack Of Assurance Of Sterility.
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
SCA Pharmaceuticals
Class I - Dangerous
Lack Of Assurance Of Sterility.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.