Class III · Low risk Terminated
Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets…
Reason Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class III · Low risk Terminated
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents…
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions…
Class III · Low risk Terminated
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit…
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions…
Class III · Low risk Terminated
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854…
Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP…
Class III · Low risk Terminated
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited…
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India…
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization…
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA…
Reason Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18…
Class III · Low risk Terminated
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par…
Reason Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class III · Low risk Terminated
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake…
Reason Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class III · Low risk Terminated
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC…
Reason Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class III · Low risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets…
Reason Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset…
Reason Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed…
Class III · Low risk Terminated
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices…
Class III · Low risk Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6…
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only…
Reason Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk Terminated
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed…
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed…
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed…
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed…
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by…
Reason Defective Container: Customer complaints of punctures in the bottle.