Class III · Low risk
Loperamide HCL Tablets USP
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
FDA Drug Recalls
26 recalls · Class III, newest first
Class III · Low risk
ERBITUX CETUXIMAB Injection
Labeling: Missing label; potential for missing primary container label on the vial.
Class III · Low risk
Curaplex Epi Safe Kit
Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
Class III · Low risk
Tadalafil SR 12 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Tadalafil SR 7 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Progesterone SR 200 mg Capsules
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Progesterone SR 100 mg Capsules
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class III · Low risk
treatNOW ABILIFY
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk
treatNOW ABILIFY
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk
Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class III · Low risk
Testosterone 200 mg Pellet
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Class III · Low risk
Diazepam Rectal Gel
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class III · Low risk
Equate ClearLAX
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class III · Low risk
TESTOSTERONE 200 mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk
ESTRADIOL 20mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class III · Low risk
Riomet (metformin hydrochloride oral solution)
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class III · Low risk
Calendula Cream
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Class III · Low risk
Tramadol Hydrochloride 50 mg tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Indomethacin Capsules USP
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class III · Low risk
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.