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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/ML INJECTABLE, Rx… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC B12 25/50/50/1+B6 100 MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compounding Pharmacy,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/ML INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 Tadalafil Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC… Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II November 17, 2021 GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 CEFIXIME Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken… Failed Impurities/Degradation Specifications Ascend Laboratories LLC Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #2 INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC… cGMP Deviations: Product manufactured with contaminated raw ingredient. Precision Dose Inc. Terminated
Class II November 17, 2021 Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup:… cGMP Deviations: Product manufactured with contaminated raw ingredient. Precision Dose Inc. Terminated
Class III November 17, 2021 Cetirizine Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications… Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in… A-S Medication Solutions LLC. Terminated
Class II November 17, 2021 Ezetimibe and Simvastatin Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only,… Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found… Golden State Medical Supply Inc. Terminated
Class II November 17, 2021 Ezetimibe and Simvastatin Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured… Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity Golden State Medical Supply Inc. Terminated
Class II November 10, 2021 Irbesartan Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Lupin Pharmaceuticals Inc. Terminated
Class II November 10, 2021 Irbesartan Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Lupin Pharmaceuticals Inc. Terminated
Class II November 10, 2021 Irbesartan Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC#… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Lupin Pharmaceuticals Inc. Terminated
Class I November 10, 2021 Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC… Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain… Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals Completed
Class I November 10, 2021 Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf.… Presence of Particulate Matter: Identified as Glass Particles MERCK SHARP & DOHME CORP Terminated
Class II November 10, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Lupin Pharmaceuticals Inc. Terminated
Class II November 10, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Lupin Pharmaceuticals Inc. Terminated
Class II November 10, 2021 Ezetimibe and Simvastatin Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Dr. Reddy's Laboratories, Inc. Terminated
Class II November 10, 2021 Ezetimibe and Simvastatin Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Dr. Reddy's Laboratories, Inc. Terminated
Class II November 10, 2021 Ezetimibe and Simvastatin Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Dr. Reddy's Laboratories, Inc. Terminated
Class II November 10, 2021 Ezetimibe and Simvastatin Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only,… Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found… Dr. Reddy's Laboratories, Inc. Terminated
Class II November 10, 2021 Ezetimibe and Simvastatin Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Dr. Reddy's Laboratories, Inc. Terminated
Class III November 3, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin… Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay… Lupin Pharmaceuticals Inc. Terminated
Class II November 3, 2021 TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg,… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk,… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain… Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Rizatriptan Benzoate Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose… Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. MACLEODS PHARMA USA, INC Terminated
Class II November 3, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain… Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Rizatriptan Benzoate Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose… Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. MACLEODS PHARMA USA, INC Terminated
Class II November 3, 2021 ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg)… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class III November 3, 2021 KIRKLAND SIGNATURE ALLERCLEAR D 24 HR AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets,… Failed Moisture Limits SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III November 3, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID),… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Ultra Seal Corporation Terminated
Class II November 3, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 3, 2021 MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class III November 3, 2021 Rizatriptan Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose… Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. MACLEODS PHARMA USA, INC Terminated
Class III November 3, 2021 Loratadine and Pseudoephedrine Sulfate Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate,… Failed Moisture Limits SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II October 27, 2021 Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%,… CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues. Sanitor Corporation Terminated
Class I October 27, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ… Chemical contamination; presence of benzene Beiersdorf Inc Terminated
Class II October 27, 2021 GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10… Failed Dissolution Specifications: results were above specification. American Health Packaging Terminated
Class I October 27, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5… Chemical contamination; presence of benzene Beiersdorf Inc Terminated
Class II October 27, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5… cGMP Deviations Beiersdorf Inc Terminated
Class I October 27, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5… Chemical contamination; presence of benzene Beiersdorf Inc Terminated
Class II October 27, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5… cGMP Deviations Beiersdorf Inc Terminated
Class I October 27, 2021 Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ… Chemical contamination; presence of benzene Beiersdorf Inc Terminated
Class II October 27, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ… cGMP Deviations Beiersdorf Inc Terminated
Class I October 27, 2021 Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%,… Chemical contamination; presence of benzene Beiersdorf Inc Terminated
Class II October 27, 2021 Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for:… Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial,… Piramal Critical Care, Inc. Terminated
Class II October 27, 2021 AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Teva Pharmaceuticals USA Terminated
Class II October 27, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Teva Pharmaceuticals USA Terminated
Class II October 27, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Teva Pharmaceuticals USA Terminated
Class II October 27, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Teva Pharmaceuticals USA Terminated
Class II October 27, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Teva Pharmaceuticals USA Terminated
Class II October 27, 2021 Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium),… CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. Dr. Reddy's Laboratories, Inc. Terminated
Class II October 27, 2021 Imipramine Pamoate Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin… Out of specification result observed in a dissolution test at the 9-month long term stability time point. Lupin Pharmaceuticals Inc. Terminated
Class II October 20, 2021 Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM… Lack of Assurance of Sterility SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class I October 20, 2021 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial;… SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of… Eli Lilly & Company Terminated
Class II October 20, 2021 Potassium Chloride Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only,… Failed Dissolution Specifications Strides Pharma Inc. Terminated
Class I October 13, 2021 ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by… Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil Alpha-Tek LLC Ongoing
Class II October 13, 2021 Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising… Labeling: Incorrect Instructions RISING PHARMACEUTICALS Ongoing
Class II October 13, 2021 Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle,… Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the… Akorn, Inc. Terminated
Class II October 13, 2021 Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose… Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. AMIVAS (US), LLC Terminated
Class I October 13, 2021 FIRVANQ Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit… Product Mix-up: Incorrect diluent component included in the kit. Azurity Pharmaceuticals, Inc. Terminated
Class I October 6, 2021 Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only,… Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic… Jacobus Pharmaceutical Company Inc. Terminated
Class II October 6, 2021 Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram;… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9;… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY:… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured… Finished product specification did not meet USP specifications. Monarch PCM, LLC Terminated
Class II October 6, 2021 Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class III October 6, 2021 Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ… Subpotent Drug New Vision Pharmaceuticals LLC Terminated
Class II October 6, 2021 Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only,… Lack of Assurance of Sterility New Vitalis Pharmacy LLC dba New Vitalis Pharmacy Terminated
Class III October 6, 2021 CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8… Subpotent Drug New Vision Pharmaceuticals LLC Terminated
Class II October 6, 2021 Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dram, UPC 7… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains:… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product,… Lack of sterility assurance. IntegraDose Compounding Services LLC Terminated
Class II October 6, 2021 La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33969 5; 15X… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose… Lack of sterility assurance. IntegraDose Compounding Services LLC Terminated
Class II October 6, 2021 Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx… CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial… American Health Packaging Terminated
Class II October 6, 2021 Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Washington Homeopathic Products, Inc. Terminated
Class II October 6, 2021 Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class I October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50,… Chemical Contamination: presence of benzene Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class I October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+,… Chemical Contamination: presence of benzene Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%),… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70,… cGMP Deviations Johnson & Johnson Consumer, Inc. Ongoing
Class II October 6, 2021 Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only,… Failed Dissolution Specifications Viatris Terminated
Class II October 6, 2021 Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53… Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing. SigmaPharm Laboratories LLC Terminated
Class II October 6, 2021 Morphine Sulfate Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius… Defective container: Cracked vials leading to lack of sterility assurance Fresenius Kabi USA LLC Terminated
Class II September 29, 2021 CHANTIX Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs,… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II September 29, 2021 Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL &… CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial… Morton Grove Pharmaceuticals, Inc. Completed
Class II September 29, 2021 Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx… CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Direct Rx Terminated
Class II September 29, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs,… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class I September 29, 2021 Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum,… Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count… DuPont Nutrition USA, Inc Terminated
Class II September 29, 2021 Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by:… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class I September 29, 2021 X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2 Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Phe Inc Completed
Class II September 29, 2021 Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only… Lack of Assurance of Sterility Glenmark Pharmaceuticals Inc., USA Terminated
Class III September 29, 2021 Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only,… Subpotency: one product for active ingredient assay and another one for preservative assay Monarch PCM, LLC Terminated
Class II September 29, 2021 Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by:… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class II September 29, 2021 Metoprolol Tartrate Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by:… Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. Aurobindo Pharma USA Inc. Terminated