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-0751-2021 | 07-19-2021 | Econazole 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 Mispack | Teligent Pharma, Inc. / 14688 tubes | Class II | Terminated |
| D-0001-2022 | 07-16-2021 | ALPHA 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 tadalafil | Alpha-Tek LLC / Unknown | Class I | Ongoing |
| D-0696-2021 | 07-15-2021 | Azelaic 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 York | cGMP Deviations | API Solutions Inc. / 1 bottle | Class II | Terminated |
| D-0695-2021 | 07-15-2021 | Estriol 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: 46144-300-01 | cGMP Deviations | API Solutions Inc. / 20 bottles | Class II | Terminated |
| D-0839-2021 | 07-14-2021 | Neutrogena 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 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 3,985,392 cans | Class II | Ongoing |
| D-0849-2021 | 07-14-2021 | Neutrogena 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 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / N/A | Class II | Ongoing |
| D-0844-2021 | 07-14-2021 | Neutrogena 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 9 | Chemical Contamination: presence of benzene | Johnson & Johnson Consumer, Inc. / 1,437,804 cans | Class I | Ongoing |
| D-0840-2021 | 07-14-2021 | Neutrogena 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 7 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 405,264 cans | Class II | Ongoing |
| D-0833-2021 | 07-14-2021 | Neutrogena 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 08858 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 1,265,724 b) 1,052,544cans | Class II | Ongoing |
| D-0841-2021 | 07-14-2021 | Neutrogena 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 4 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 876,960 cans | Class II | Ongoing |
| D-0832-2021 | 07-14-2021 | Neutrogena 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 Deviations | Johnson & Johnson Consumer, Inc. / a) 223,884; b) 245,880 cans | Class II | Ongoing |
| D-0843-2021 | 07-14-2021 | Neutrogena 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 2 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 88,380 cans | Class II | Ongoing |
| D-0846-2021 | 07-14-2021 | Neutrogena 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 08858 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 3,672,204; b) 11,180 cans | Class II | Ongoing |
| D-0837-2021 | 07-14-2021 | Neutrogena 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 Deviations | Johnson & Johnson Consumer, Inc. / a) 5oz-1,282,488; b) 8oz-475,476 cans | Class II | Ongoing |
| D-0834-2021 | 07-14-2021 | Neutrogena 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 2 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 867,816 cans | Class II | Ongoing |
| D-0848-2021 | 07-14-2021 | Neutrogena 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 5 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 411,180 cans | Class II | Ongoing |
| D-0835-2021 | 07-14-2021 | Neutrogena 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 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 678,384 cans | Class II | Ongoing |
| D-0831-2021 | 07-14-2021 | Aveeno 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 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 134,280 cans | Class II | Ongoing |
| D-0842-2021 | 07-14-2021 | Neutrogena 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 0 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 1,448,520 cans | Class II | Ongoing |
| D-0850-2021 | 07-14-2021 | Neutrogena 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 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / N/A | Class II | Ongoing |
| D-0836-2021 | 07-14-2021 | Neutrogena 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 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 1,611,180 cans | Class II | Ongoing |
| D-0838-2021 | 07-14-2021 | Neutrogena 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 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 2,724,480 cans | Class II | Ongoing |
| D-0847-2021 | 07-14-2021 | Neutrogena 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 7 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 196,380 cans | Class II | Ongoing |
| D-0845-2021 | 07-14-2021 | Neutrogena 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 6 | Chemical Contamination: presence of benzene | Johnson & Johnson Consumer, Inc. / 387,648 cans | Class I | Ongoing |
| D-0749-2021 | 07-14-2021 | Vy&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 boxes | Class I | Ongoing |
| D-0793-2021 | 07-12-2021 | QiYu 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 74447-010 | Subpotent | NATIVE PROMOTIONS, INC / 4,320 bottles | Class II | Terminated |
| D-0693-2021 | 07-09-2021 | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Assurance of Sterility | Innoveix Pharmaceuticals Inc / 1,316 vials | Class II | Completed |
| D-0692-2021 | 07-09-2021 | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Assurance of Sterility | Innoveix Pharmaceuticals Inc / 728 vials | Class II | Completed |
| D-0665-2021 | 07-07-2021 | Acetaminophen 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 46122-649-71 | Labeling: 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 bottles | Class III | Terminated |
| D-0719-2021 | 07-07-2021 | Sulfamethoxazole 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 bottles | Class II | Terminated |
| D-0652-2021 | 07-02-2021 | NIFEdipine 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 each | Class II | Terminated |
| D-0772-2021 | 07-02-2021 | Atovaquone 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 bottles | Class I | Terminated |
| D-0803-2021 | 06-30-2021 | MIC+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 1-888-3PROMIS | Lack of processing controls | Promise Pharmacy, LLC / 57 vials | Class II | Terminated |
| D-0697-2021 | 06-30-2021 | Global 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 80253-001-01 | CGMP Deviations: Does not meet monograph for denaturant. | Cascade Kelly Holdings LLC / | Class II | Terminated |
| D-0698-2021 | 06-30-2021 | Global 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 80253-001-02 | CGMP Deviations: Does not meet monograph for denaturant. | Cascade Kelly Holdings LLC / | Class II | Terminated |
| D-0720-2021 | 06-29-2021 | Zyprexa 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 vials | Class II | Terminated |
| D-0651-2021 | 06-25-2021 | Xylocaine-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 vials | Class II | Terminated |
| D-0655-2021 | 06-23-2021 | LEUKINE (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 vials | Class III | Terminated |
| D-0690-2021 | 06-22-2021 | Erythromycin 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 Specifications | Teligent Pharma, Inc. / 22,824 tubes | Class III | Terminated |
| D-0689-2021 | 06-22-2021 | Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59 | Failed Impurities/Degradation Specifications | Teligent Pharma, Inc. / 7872 tubes | Class III | Terminated |
| D-0643-2021 | 06-22-2021 | QiYu 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 716288 | Subpotent | HOYU(US) LOGISTICS INC / 30,880 bottles | Class II | Ongoing |
| D-0691-2021 | 06-22-2021 | Limar 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 301587 | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | Ardil Comercial S.R.L. / 1,260 bottles | Class I | Ongoing |
| D-0694-2021 | 06-21-2021 | Prairie 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, Oklahoma | Hand sanitizer packaged in bottles that resemble beverage containers. | Prairie Wolf Spirits / Unknown | Class I | Terminated |
| D-0661-2021 | 06-18-2021 | Topotecan 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# 0703-4714-71 | Presence 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 vials | Class I | Terminated |
| D-0653-2021 | 06-18-2021 | B-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 | Superpotent | Grato Holdings, Inc. / 1480 bottles | Class III | Terminated |
| D-0729-2021 | 06-16-2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10 | cGMP deviations: Discolored acetaminophen | Spirit Pharmaceuticals / N/A | Class II | Terminated |
| D-0660-2021 | 06-10-2021 | Solifenacin 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 Deviations | CIPLA / 7228 bottles | Class II | Terminated |
| D-0631-2021 | 06-09-2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13 | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | AVKARE Inc. / 10 cartons | Class III | Terminated |
| D-0632-2021 | 06-09-2021 | QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou | Subpotent | World Source Llc / 6,300 bottles | Class II | Terminated |
| D-0701-2021 | 06-09-2021 | Chantix (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 limit | Pfizer Inc. / 69,6396 bottles | Class II | Ongoing |
| D-0650-2021 | 06-09-2021 | Xolair (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 syringes | Class II | Terminated |
| D-0699-2021 | 06-09-2021 | Chantix (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 limit | Pfizer Inc. / 59,232 bottles | Class II | Ongoing |
| D-0700-2021 | 06-09-2021 | Chantix (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 limit | Pfizer Inc. / 350,985 cartons | Class II | Ongoing |
| D-0639-2021 | 06-08-2021 | Phytonadione 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 68682-170-30 | Failed Impurities/Degradation Specifications | Bausch Health Companies, Inc. / 37,797 bottles | Class III | Terminated |
| D-0638-2021 | 06-08-2021 | Mephyton (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 Specifications | Bausch Health Companies, Inc. / 2,691 bottles | Class III | Terminated |
| D-0648-2021 | 06-08-2021 | Ketamine 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: 73463-0100-01 | Labeling: Incorrect Exp. Date: Incorrect BUD. | Prisma Health Outsourcing Facility / 109 syringes | Class III | Terminated |
| D-0629-2021 | 06-04-2021 | Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05. 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 impurities | Dr. Reddy's Laboratories, Inc. / 5984 bottles | Class III | Terminated |
| D-0640-2021 | 06-01-2021 | Metformin 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 bottles | Class II | Terminated |
| D-0630-2021 | 05-26-2021 | Levetiracetam 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 63739-795-10 | Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam | McKesson Corporation dba McKesson Drug Company / 210 cartons | Class III | Terminated |
| D-0637-2021 | 05-21-2021 | DermOtic 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 samples | Class II | Terminated |
| D-0393-2021 | 05-20-2021 | Daytrana (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 boxes | Class II | Ongoing |
| D-0394-2021 | 05-20-2021 | Daytrana (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 boxes | Class II | Ongoing |
| D-0635-2021 | 05-18-2021 | maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028 | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Miracle 8989 / Unknown | Class I | Terminated |
| D-0634-2021 | 05-18-2021 | PremierZEN 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 90006 | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Miracle 8989 / Unknown | Class I | Terminated |
| D-0633-2021 | 05-18-2021 | PremierZEN 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 90006 | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Miracle 8989 / Unknown | Class I | Terminated |
| D-0636-2021 | 05-14-2021 | Diflorasone 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 tubes | Class II | Terminated |
| D-0624-2021 | 05-14-2021 | READYPREP 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 packs | Class III | Terminated |
| D-0598-2021 | 05-13-2021 | Native 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 Fluoride | Accupac, Inc. / 2,261 cases/24 tubes per case = 54,264 tubes | Class II | Terminated |
| D-0780-2021 | 05-12-2021 | MEDICALLY 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 bottles | Class I | Ongoing |
| D-0783-2021 | 05-12-2021 | MEDICALLY 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/A | Class II | Ongoing |
| D-0782-2021 | 05-12-2021 | MEDICALLY 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/A | Class II | Ongoing |
| D-0781-2021 | 05-12-2021 | MEDICALLY 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 | 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 / N/A | Class I | Ongoing |
| D-0778-2021 | 05-12-2021 | MEDICALLY 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 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 / 50,000 bottles | Class II | Ongoing |
| D-0779-2021 | 05-12-2021 | MEDICALLY 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 7 | 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 / 50,000 bottles | Class II | Ongoing |
| D-0813-2021 | 05-12-2021 | Sirolimus 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 Specifications | American Health Packaging / 290 cartons | Class III | Terminated |
| D-0654-2021 | 05-11-2021 | Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0 | Marketed 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 capsules | Class I | Terminated |
| D-0628-2021 | 05-11-2021 | Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg | Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine | DASH XCLUSIVE / 25 pieces (boxes containing 15 sachets) | Class II | Ongoing |
| D-0645-2021 | 05-11-2021 | DiBAR 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 quantity | Class II | Terminated |
| D-0644-2021 | 05-11-2021 | DiBAR 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 quantity | Class I | Terminated |
| D-0646-2021 | 05-11-2021 | ProtectoRx (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 quantity | Class II | Terminated |
| D-0647-2021 | 05-11-2021 | ADVANCE 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 1 | 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 quantity | Class II | Terminated |
| D-0718-2021 | 05-11-2021 | C-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 38117 | Non-Sterility | People's Custom Rx and Clinical Care, LLC / 14 vials | Class I | Terminated |
| D-0391-2021 | 05-07-2021 | Cequa (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/A | Class III | Terminated |
| D-0602-2021 | 05-05-2021 | BusPIRone 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/Capsules | Oxford Pharmaceuticals, LLC / 6,864 bottles | Class II | Completed |
| D-0372-2021 | 05-04-2021 | Metformin 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 bottles | Class II | Terminated |
| D-0600-2021 | 05-04-2021 | Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 Package NDCs: 0597-0039-37; 0597-0040-37; 0597-0041-37 | Subpotent Drug | Boehringer Ingelheim Pharmaceuticals, Inc. / 15,198 bottles (30 tablets per bottle) | Class II | Terminated |
| D-0599-2021 | 05-04-2021 | Atorvastatin 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 impurities | Dr. Reddy's Laboratories, Inc. / 2980 500 count -bottles | Class III | Terminated |
| D-0384-2021 | 05-03-2021 | Sterile 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 vials | Class II | Terminated |
| D-0627-2021 | 05-03-2021 | 1% 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, USP | PFIZER, INC / 139,050 vials | Class I | Terminated |
| D-0626-2021 | 05-03-2021 | 0.5% 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, USP | PFIZER, INC / 163,957 vials | Class I | Terminated |
| D-0601-2021 | 05-03-2021 | Thiamine 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 cartons | Class III | Terminated |
| D-0390-2021 | 04-29-2021 | Cefixime 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 Drug | Lupin Pharmaceuticals Inc. / 3,138 bottles | Class II | Terminated |
| D-0398-2021 | 04-29-2021 | NP 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 Drug | Acella Pharmaceuticals, LLC / 79,344 bottles | Class I | Terminated |
| D-0399-2021 | 04-29-2021 | NP 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 Drug | Acella Pharmaceuticals, LLC / a) 69,289 bottles; b) 9,076 bottles | Class I | Terminated |
| D-0395-2021 | 04-29-2021 | NP 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 Drug | Acella Pharmaceuticals, LLC / a) 66,155 bottles; b) 26,212 bottles | Class I | Terminated |
| D-0396-2021 | 04-29-2021 | NP 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 Drug | Acella Pharmaceuticals, LLC / a) 113,019 bottles; b) 44,900 bottles | Class I | Terminated |
| D-0397-2021 | 04-29-2021 | NP 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 Drug | Acella Pharmaceuticals, LLC / 154,726 bottles | Class I | Terminated |
| D-0392-2021 | 04-29-2021 | Olmesartan 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/Capsule | Ascend Laboratories LLC / 34296 bottles | Class III | Terminated |
| D-0385-2021 | 04-28-2021 | Preferred 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 #: 68788-6932-1 | CMGP 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 II | Ongoing |
| D-0604-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 25 cases | Class III | Terminated |
