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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1257-2020 | 04-18-2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11 | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers. | B. Braun Medical Inc / 22,488 Duplex containers | Class I | Terminated |
| D-1253-2020 | 04-15-2020 | Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15 Package NDCs: 60846-301-15 | CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. | Amneal Pharmaceuticals of New York, LLC / 11258 bottles | Class II | Terminated |
| D-1252-2020 | 04-15-2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 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: low out of specification (OOS) test result observed in long term stability study. | Lupin Pharmaceuticals Inc. / 4,518 bottles | Class II | Terminated |
| D-1246-2020 | 04-15-2020 | Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433 | cGMP Deviations | H J Harkins Company Inc dba Pharma Pac / 9,000 tablets | Class II | Terminated |
| D-1489-2020 | 04-15-2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE. | Chemical Contamination; product contains elevated levels of lead | Summitt Labs / 236 bottles | Class I | Terminated |
| D-1244-2020 | 04-14-2020 | Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100 | cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. | B & B Pharmaceuticals, Inc. / 3,825 grams | Class II | Terminated |
| D-1269-2020 | 04-14-2020 | Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil. | MasterPharm LLC / 7260 capsules | Class I | Terminated |
| D-1223-2020 | 04-06-2020 | Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1179-2020 | 04-06-2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1211-2020 | 04-06-2020 | Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1207-2020 | 04-06-2020 | Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1221-2020 | 04-06-2020 | Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1201-2020 | 04-06-2020 | Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1227-2020 | 04-06-2020 | Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 bottles | Class II | Terminated |
| D-1202-2020 | 04-06-2020 | Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1200-2020 | 04-06-2020 | Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1206-2020 | 04-06-2020 | Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1191-2020 | 04-06-2020 | Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 3 bottles | Class II | Terminated |
| D-1214-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1175-2020 | 04-06-2020 | Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 8 tubes | Class II | Terminated |
| D-1190-2020 | 04-06-2020 | Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1198-2020 | 04-06-2020 | Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1187-2020 | 04-06-2020 | Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1199-2020 | 04-06-2020 | Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1176-2020 | 04-06-2020 | Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 4 tubes | Class II | Terminated |
| D-1226-2020 | 04-06-2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 boxes | Class II | Terminated |
| D-1209-2020 | 04-06-2020 | Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 box | Class II | Terminated |
| D-1228-2020 | 04-06-2020 | Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1219-2020 | 04-06-2020 | Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1218-2020 | 04-06-2020 | Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1217-2020 | 04-06-2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1178-2020 | 04-06-2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1181-2020 | 04-06-2020 | Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1192-2020 | 04-06-2020 | Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1180-2020 | 04-06-2020 | Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1185-2020 | 04-06-2020 | Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1216-2020 | 04-06-2020 | Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1210-2020 | 04-06-2020 | Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1182-2020 | 04-06-2020 | Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 7 tubes | Class II | Terminated |
| D-1177-2020 | 04-06-2020 | Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1188-2020 | 04-06-2020 | Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1183-2020 | 04-06-2020 | Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1204-2020 | 04-06-2020 | Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1189-2020 | 04-06-2020 | Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1220-2020 | 04-06-2020 | Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1225-2020 | 04-06-2020 | Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1195-2020 | 04-06-2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 box | Class II | Terminated |
| D-1222-2020 | 04-06-2020 | Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1194-2020 | 04-06-2020 | Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1203-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1186-2020 | 04-06-2020 | Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1208-2020 | 04-06-2020 | Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1184-2020 | 04-06-2020 | Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 3 bottles | Class II | Terminated |
| D-1197-2020 | 04-06-2020 | Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1193-2020 | 04-06-2020 | Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1205-2020 | 04-06-2020 | Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1213-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1212-2020 | 04-06-2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1196-2020 | 04-06-2020 | Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1215-2020 | 04-06-2020 | Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1224-2020 | 04-06-2020 | Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1238-2020 | 04-03-2020 | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / | Class II | Terminated |
| D-1079-2020 | 04-01-2020 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets. | Lupin Pharmaceuticals Inc. / 25,944 bottles | Class II | Terminated |
| D-1249-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 14,142 30-count boxes | Class II | Terminated |
| D-1248-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 5,614 30-count boxes | Class II | Terminated |
| D-1247-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 7957 30-count boxes | Class II | Terminated |
| D-1071-2020 | 03-30-2020 | Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01 | Failed Impurities/Degradation Specification: Presence of unknown impurity observed. | Par Pharmaceutical Inc. / 29,352 bottles | Class II | Terminated |
| D-1099-2020 | 03-26-2020 | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1097-2020 | 03-26-2020 | Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1098-2020 | 03-26-2020 | Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1104-2020 | 03-26-2020 | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. / a) 12,168; b) 17,196; c) 3,890 | Class II | Terminated |
| D-1095-2020 | 03-26-2020 | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1103-2020 | 03-26-2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. / a) 2,904; b) 14,316; c) 1,368 bottles | Class II | Terminated |
| D-1096-2020 | 03-26-2020 | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1101-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| D-1102-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| D-1100-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| D-1258-2020 | 03-25-2020 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02 | Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing. | Akorn Inc / 15,170 ampules | Class III | Terminated |
| D-1163-2020 | 03-24-2020 | Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1108-2020 | 03-24-2020 | Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1124-2020 | 03-24-2020 | Flare Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1118-2020 | 03-24-2020 | DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1141-2020 | 03-24-2020 | Lump Shrinker, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1116-2020 | 03-24-2020 | Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1134-2020 | 03-24-2020 | Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1152-2020 | 03-24-2020 | Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1139-2020 | 03-24-2020 | Immune-2100, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1121-2020 | 03-24-2020 | Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1138-2020 | 03-24-2020 | Herpes-P, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1157-2020 | 03-24-2020 | Skin Cleanser, 500mg Capsules, 90-count bottles2, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1132-2020 | 03-24-2020 | Herpes-G, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1135-2020 | 03-24-2020 | Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1165-2020 | 03-24-2020 | Sweat Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1136-2020 | 03-24-2020 | Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1144-2020 | 03-24-2020 | Metabolic Booster. 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1145-2020 | 03-24-2020 | Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1127-2020 | 03-24-2020 | Fungo Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1126-2020 | 03-24-2020 | Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1137-2020 | 03-24-2020 | Herpes-G, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1168-2020 | 03-24-2020 | Vertigo Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
