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.
FDA Drug Recalls
530 recalls, newest first
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 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
Class I · High risk
Man King Capsules
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Class I · High risk
Hard Ten Days Capsule
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.