Class I - Dangerous
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
Class I - Dangerous
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
Subpotent Drug
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
Oxford Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Class I - Dangerous
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I - Dangerous
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
Cardinal Health
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
Cardinal Health
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)
Cardinal Health
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.