Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
FDA drug recalls in 2012
Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
Class II · Moderate risk
Multihance Multipack
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Class III · Low risk
Bracco Diagnostics multihance
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Class II · Moderate risk
Carbon Dioxide
Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.
Class II · Moderate risk
Dr. Reddy's Ciprofloxacin Tablets
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Class II · Moderate risk
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Class II · Moderate risk
Meloxicam Tablets
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Class III · Low risk
Magnesium Sulfate in Water for Injection
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Class II · Moderate risk
Mefloquine HCL Tablets
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class II · Moderate risk
Daytrana (Methylphenidate)
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Class III · Low risk
DermaZinc Spray
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Class III · Low risk
Balnetar Therapeutic Tar Bath
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Class I · High risk
Blue Male Enhancement Pill
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Class III · Low risk
Ciprofloxacin Tablets
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Class II · Moderate risk
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Class II · Moderate risk
Nisoldipine Extended Release Tablets
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Class II · Moderate risk
Thyro-Tab.075 mg.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class I · High risk
Japan Weight Loss Blue Capsules
Marketed Without an Approved ANDA/NDA: presence of sibutramine