Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on July 04, 2025 and include a total of 16930 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0751-202107-19-2021Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.Correct Labeled Product MispackTeligent Pharma, Inc. / 14688 tubesClass IITerminated
D-0001-202207-16-2021ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafilAlpha-Tek LLC / UnknownClass IOngoing
D-0696-202107-15-2021Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New YorkcGMP DeviationsAPI Solutions Inc. / 1 bottleClass IITerminated
D-0695-202107-15-2021Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01cGMP DeviationsAPI Solutions Inc. / 20 bottlesClass IITerminated
D-0839-202107-14-2021Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6cGMP DeviationsJohnson & Johnson Consumer, Inc. / 3,985,392 cansClass IIOngoing
D-0849-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9cGMP DeviationsJohnson & Johnson Consumer, Inc. / N/AClass IIOngoing
D-0844-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9Chemical Contamination: presence of benzeneJohnson & Johnson Consumer, Inc. / 1,437,804 cansClass IOngoing
D-0840-202107-14-2021Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7cGMP DeviationsJohnson & Johnson Consumer, Inc. / 405,264 cansClass IIOngoing
D-0833-202107-14-2021Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858cGMP DeviationsJohnson & Johnson Consumer, Inc. / a) 1,265,724 b) 1,052,544cansClass IIOngoing
D-0841-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4cGMP DeviationsJohnson & Johnson Consumer, Inc. / 876,960 cansClass IIOngoing
D-0832-202107-14-2021Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858,cGMP DeviationsJohnson & Johnson Consumer, Inc. / a) 223,884; b) 245,880 cansClass IIOngoing
D-0843-202107-14-2021Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2cGMP DeviationsJohnson & Johnson Consumer, Inc. / 88,380 cansClass IIOngoing
D-0846-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858cGMP DeviationsJohnson & Johnson Consumer, Inc. / a) 3,672,204; b) 11,180 cansClass IIOngoing
D-0837-202107-14-2021Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858,cGMP DeviationsJohnson & Johnson Consumer, Inc. / a) 5oz-1,282,488; b) 8oz-475,476 cansClass IIOngoing
D-0834-202107-14-2021Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2cGMP DeviationsJohnson & Johnson Consumer, Inc. / 867,816 cansClass IIOngoing
D-0848-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5cGMP DeviationsJohnson & Johnson Consumer, Inc. / 411,180 cansClass IIOngoing
D-0835-202107-14-2021Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9cGMP DeviationsJohnson & Johnson Consumer, Inc. / 678,384 cansClass IIOngoing
D-0831-202107-14-2021Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9cGMP DeviationsJohnson & Johnson Consumer, Inc. / 134,280 cansClass IIOngoing
D-0842-202107-14-2021Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11033 0cGMP DeviationsJohnson & Johnson Consumer, Inc. / 1,448,520 cansClass IIOngoing
D-0850-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6cGMP DeviationsJohnson & Johnson Consumer, Inc. / N/AClass IIOngoing
D-0836-202107-14-2021Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6cGMP DeviationsJohnson & Johnson Consumer, Inc. / 1,611,180 cansClass IIOngoing
D-0838-202107-14-2021Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9cGMP DeviationsJohnson & Johnson Consumer, Inc. / 2,724,480 cansClass IIOngoing
D-0847-202107-14-2021Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7cGMP DeviationsJohnson & Johnson Consumer, Inc. / 196,380 cansClass IIOngoing
D-0845-202107-14-2021Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6Chemical Contamination: presence of benzeneJohnson & Johnson Consumer, Inc. / 387,648 cansClass IOngoing
D-0749-202107-14-2021Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.Qikmoov LLC / 591 boxesClass IOngoing
D-0793-202107-12-2021QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010SubpotentNATIVE PROMOTIONS, INC / 4,320 bottlesClass IITerminated
D-0693-202107-09-2021Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910Lack of Assurance of SterilityInnoveix Pharmaceuticals Inc / 1,316 vialsClass IICompleted
D-0692-202107-09-2021Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910Lack of Assurance of SterilityInnoveix Pharmaceuticals Inc / 728 vialsClass IICompleted
D-0665-202107-07-2021Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'LNK International, Inc. / 8,472 bottlesClass IIITerminated
D-0719-202107-07-2021Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Package NDCs: 65862-419-20; 65862-419-01; 65862-419-05; 65862-419-99; 65862-420-20; 65862-420-01; 65862-420-05; 65862-420-99
Presence of Foreign Substance- Potential of metal contamination.Aurobindo Pharma USA Inc. / 3800 bottlesClass IITerminated
D-0652-202107-02-2021NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
Package NDCs: 0904-7080-06; 0904-7080-61; 0904-7081-06; 0904-7081-61; 0904-7082-04; 0904-7082-06
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.The Harvard Drug Group / 504 Cartons of 50 count each; 372 Cartons of 100 count eachClass IITerminated
D-0772-202107-02-2021Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Package NDCs: 10702-223-21
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.KVK-Tech, Inc. / 1,692 bottlesClass ITerminated
D-0803-202106-30-2021MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMISLack of processing controlsPromise Pharmacy, LLC / 57 vialsClass IITerminated
D-0697-202106-30-2021Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01CGMP Deviations: Does not meet monograph for denaturant.Cascade Kelly Holdings LLC / Class IITerminated
D-0698-202106-30-2021Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02CGMP Deviations: Does not meet monograph for denaturant.Cascade Kelly Holdings LLC / Class IITerminated
D-0720-202106-29-2021Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Package NDCs: 0002-4112-30; 0002-4115-30; 0002-4116-30; 0002-4117-30; 0002-4415-30; 0002-4420-30; 0002-4453-01; 0002-4453-85; 0002-4454-01; 0002-4454-85; 0002-4455-01; 0002-4455-85; 0002-4456-01; 0002-4456-85; 0002-7597-01
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.Eli Lilly & Company / 36,540 vialsClass IITerminated
D-0651-202106-25-2021Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31
Low out of specification results for epinephrine assay.Fresenius Kabi USA LLC / 234,800 vialsClass IITerminated
D-0655-202106-23-2021LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5
Package NDCs: 71837-5843-1; 71837-5843-5
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.Partner Therapeutics Inc / 32,260 vialsClass IIITerminated
D-0690-202106-22-2021Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,Failed Impurities/Degradation SpecificationsTeligent Pharma, Inc. / 22,824 tubesClass IIITerminated
D-0689-202106-22-2021Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59Failed Impurities/Degradation SpecificationsTeligent Pharma, Inc. / 7872 tubesClass IIITerminated
D-0643-202106-22-2021QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288SubpotentHOYU(US) LOGISTICS INC / 30,880 bottlesClass IIOngoing
D-0691-202106-22-2021Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.Ardil Comercial S.R.L. / 1,260 bottlesClass IOngoing
D-0694-202106-21-2021Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, OklahomaHand sanitizer packaged in bottles that resemble beverage containers.Prairie Wolf Spirits / UnknownClass ITerminated
D-0661-202106-18-2021Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.Teva Pharmaceuticals USA / 10,425 vialsClass ITerminated
D-0653-202106-18-2021B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1
Package NDCs: 43857-0576-1
SuperpotentGrato Holdings, Inc. / 1480 bottlesClass IIITerminated
D-0729-202106-16-2021Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10cGMP deviations: Discolored acetaminophenSpirit Pharmaceuticals / N/AClass IITerminated
D-0660-202106-10-2021Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
Package NDCs: 69097-259-02; 69097-259-05; 69097-259-15; 69097-261-02; 69097-261-05; 69097-261-15
CGMP DeviationsCIPLA / 7228 bottlesClass IITerminated
D-0631-202106-09-2021Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.AVKARE Inc. / 10 cartonsClass IIITerminated
D-0632-202106-09-2021QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, GuanzhouSubpotentWorld Source Llc / 6,300 bottlesClass IITerminated
D-0701-202106-09-2021Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limitPfizer Inc. / 69,6396 bottlesClass IIOngoing
D-0650-202106-09-2021Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.Genentech Inc / 88,620 prefilled syringesClass IITerminated
D-0699-202106-09-2021Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limitPfizer Inc. / 59,232 bottlesClass IIOngoing
D-0700-202106-09-2021Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limitPfizer Inc. / 350,985 cartonsClass IIOngoing
D-0639-202106-08-2021Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30Failed Impurities/Degradation SpecificationsBausch Health Companies, Inc. / 37,797 bottlesClass IIITerminated
D-0638-202106-08-2021Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.Failed Impurities/Degradation SpecificationsBausch Health Companies, Inc. / 2,691 bottlesClass IIITerminated
D-0648-202106-08-2021Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01Labeling: Incorrect Exp. Date: Incorrect BUD.Prisma Health Outsourcing Facility / 109 syringesClass IIITerminated
D-0629-202106-04-2021Atorvastatin 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.
Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impuritiesDr. Reddy's Laboratories, Inc. / 5984 bottlesClass IIITerminated
D-0640-202106-01-2021Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Package NDCs: 72578-035-01; 72578-035-05; 72578-036-01; 72578-036-05
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.VIONA PHARMACEUTICALS INC / 21240 bottlesClass IITerminated
D-0630-202105-26-2021Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10Labeling; 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 LevetiracetamMcKesson Corporation dba McKesson Drug Company / 210 cartonsClass IIITerminated
D-0637-202105-21-2021DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Package NDCs: 68791-103-20
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.Hill Dermaceuticals, Inc. / 34,561 bottles for sale; 773 bottles for samplesClass IITerminated
D-0393-202105-20-2021Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3; 68968-5552-1
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.Noven Pharmaceuticals Inc / 9,587 boxesClass IIOngoing
D-0394-202105-20-2021Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3; 68968-5553-1
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.Noven Pharmaceuticals Inc / 6,689 boxesClass IIOngoing
D-0635-202105-18-2021maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.Miracle 8989 / UnknownClass ITerminated
D-0634-202105-18-2021PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.Miracle 8989 / UnknownClass ITerminated
D-0633-202105-18-2021PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.Miracle 8989 / UnknownClass ITerminated
D-0636-202105-14-2021Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.Presence of Foreign Substance: Foreign particles observed during routine stability testing.Teligent Pharma, Inc. / 6,240 tubesClass IITerminated
D-0624-202105-14-2021READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
Package NDCs: 53329-244-01; 53329-244-03
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.Medline Industries Inc / 231,936 packsClass IIITerminated
D-0598-202105-13-2021Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9
Package NDCs: 69423-903-41
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With FluorideAccupac, Inc. / 2,261 cases/24 tubes per case = 54,264 tubesClass IITerminated
D-0780-202105-12-2021MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.Global Sanitizers LLC / 50,000 bottlesClass IOngoing
D-0783-202105-12-2021MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6 76753 00420 8 ,CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.Global Sanitizers LLC / N/AClass IIOngoing
D-0782-202105-12-2021MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.Global Sanitizers LLC / N/AClass IIOngoing
D-0781-202105-12-2021MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.Global Sanitizers LLC / N/AClass IOngoing
D-0778-202105-12-2021MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.Global Sanitizers LLC / 50,000 bottlesClass IIOngoing
D-0779-202105-12-2021MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.Global Sanitizers LLC / 50,000 bottlesClass IIOngoing
D-0813-202105-12-2021Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Package NDCs: 68084-915-95; 68084-915-25
Failed Impurities/Degradation SpecificationsAmerican Health Packaging / 290 cartonsClass IIITerminated
D-0654-202105-11-2021Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.Yamtun7 / 36 capsulesClass ITerminated
D-0628-202105-11-2021Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 WettenbergMarketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and FluoxetineDASH XCLUSIVE / 25 pieces (boxes containing 15 sachets)Class IIOngoing
D-0645-202105-11-2021DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantityClass IITerminated
D-0644-202105-11-2021DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantityClass ITerminated
D-0646-202105-11-2021ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantityClass IITerminated
D-0647-202105-11-2021ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantityClass IITerminated
D-0718-202105-11-2021C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117Non-SterilityPeople's Custom Rx and Clinical Care, LLC / 14 vialsClass ITerminated
D-0391-202105-07-2021Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Package NDCs: 47335-506-96; 47335-507-97
Subpotent and Presence of Particulates .SUN PHARMACEUTICAL INDUSTRIES INC / N/AClass IIITerminated
D-0602-202105-05-2021BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
Package NDCs: 69584-091-10; 69584-091-50; 69584-092-10; 69584-092-50; 69584-093-10; 69584-093-50; 69584-094-06; 69584-094-18; 69584-094-50
Presence of Foreign Tablets/CapsulesOxford Pharmaceuticals, LLC / 6,864 bottlesClass IICompleted
D-0372-202105-04-2021Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.
Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01
Presence of foreign substance: identified as activated carbon.SUN PHARMACEUTICAL INDUSTRIES INC / 50868 bottlesClass IITerminated
D-0600-202105-04-2021Micardis 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
Package NDCs: 0597-0039-37; 0597-0040-37; 0597-0041-37
Subpotent DrugBoehringer Ingelheim Pharmaceuticals, Inc. / 15,198 bottles (30 tablets per bottle)Class IITerminated
D-0599-202105-04-2021Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impuritiesDr. Reddy's Laboratories, Inc. / 2980 500 count -bottlesClass IIITerminated
D-0384-202105-03-2021Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Package NDCs: 0409-4887-25; 0409-4887-99; 0409-4887-31; 0409-4887-05; 0409-4887-17; 0409-4887-10; 0409-4887-32; 0409-4887-34; 0409-4887-23; 0409-4887-20; 0409-4887-24; 0409-4887-50
Presence of Particulate Matter: particulate matter identified as an insect in one vial.Pfizer Inc. / 49,525 vialsClass IITerminated
D-0627-202105-03-20211% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01
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, USPPFIZER, INC / 139,050 vialsClass ITerminated
D-0626-202105-03-20210.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17
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, USPPFIZER, INC / 163,957 vialsClass ITerminated
D-0601-202105-03-2021Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
Package NDCs: 67457-196-00; 67457-196-02
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.Mylan Institutional LLC / 2,131 cartonsClass IIITerminated
D-0390-202104-29-2021Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08
Subpotent DrugLupin Pharmaceuticals Inc. / 3,138 bottlesClass IITerminated
D-0398-202104-29-2021NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
Package NDCs: 42192-331-30; 42192-331-01; 42192-331-10
Subpotent DrugAcella Pharmaceuticals, LLC / 79,344 bottlesClass ITerminated
D-0399-202104-29-2021NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Package NDCs: 42192-328-30; 42192-328-01; 42192-328-07
Subpotent DrugAcella Pharmaceuticals, LLC / a) 69,289 bottles; b) 9,076 bottlesClass ITerminated
D-0395-202104-29-2021NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Package NDCs: 42192-327-01; 42192-327-30; 42192-327-07
Subpotent DrugAcella Pharmaceuticals, LLC / a) 66,155 bottles; b) 26,212 bottlesClass ITerminated
D-0396-202104-29-2021NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Package NDCs: 42192-329-30; 42192-329-01; 42192-329-10; 42192-329-07
Subpotent DrugAcella Pharmaceuticals, LLC / a) 113,019 bottles; b) 44,900 bottlesClass ITerminated
D-0397-202104-29-2021NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01
Package NDCs: 42192-330-30; 42192-330-01; 42192-330-10
Subpotent DrugAcella Pharmaceuticals, LLC / 154,726 bottlesClass ITerminated
D-0392-202104-29-2021Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Package NDCs: 67877-445-30; 67877-445-90; 67877-445-05; 67877-445-10; 67877-446-30; 67877-446-90; 67877-446-05; 67877-446-10; 67877-446-33; 67877-446-84; 67877-446-74; 67877-446-38; 67877-447-30; 67877-447-90; 67877-447-05; 67877-447-10
Presence of Foreign Tablet/CapsuleAscend Laboratories LLC / 34296 bottlesClass IIITerminated
D-0385-202104-28-2021Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.Preferred Pharmaceuticals, Inc. / 147 bottles (14,700 extended release tablets)Class IIOngoing
D-0604-202104-28-2021DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50Temperature Abuse: Product exposed to temperature outside specified limits.Fresenius Medical Care Holdings, Inc. / 25 casesClass IIITerminated