Class I - Dangerous
Failed Impurities/Degradation Specifications.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Allergan Sales
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
Amerisource Health Services
Class I - Dangerous
Failed Stability Specifications
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class I - Dangerous
Superpotent drug: out of specification result for potency
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.
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
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.