Class II · Moderate risk Terminated
rocuronium Bromide
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
succinylcholine Chloride
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate 10 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% Sodium Chloride HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
rocuronium Bromide 10 mg per mL 50 mg per 5 mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
nICARdipine HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
Gentamicin 80mg/60 mL Irrigation
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Advil Liqui-Gel Mini 160+20+20 CT
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Advil Sinus Congestion and Pain/Advil Allergy and Congestion…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
*Mitomycin 0.04% Ophth DR eye drops
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
*Morphine 2 mg/mL Cassette
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
C-*Vancomycin Opthal 14 mg drops
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
C-*Albumin Eye Drop 10% S
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk Terminated
Buprenorphine Black Cherry 2 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Buprenorphine Watermelon 8 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Buprexone Banana cream 6-0.6 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets USP
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.