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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1268-2015 | 04-22-2015 | Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 16,276 Bottles | Class II | Terminated |
| D-1276-2015 | 04-22-2015 | Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 216,329 Bottles and B) 18,514 Bottles. | Class II | Terminated |
| D-1257-2015 | 04-22-2015 | Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles. | Class II | Terminated |
| D-1263-2015 | 04-22-2015 | Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 112,120 Bottles and B) 178,580 Cartons. | Class II | Terminated |
| D-1264-2015 | 04-22-2015 | Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 7,584 Bottles | Class II | Terminated |
| D-1247-2015 | 04-22-2015 | Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 37,791 Bottles | Class II | Terminated |
| D-1260-2015 | 04-22-2015 | Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 63,203 Bottles and B) 6,094 Bottles. | Class II | Terminated |
| D-1270-2015 | 04-22-2015 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA . | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons. | Class II | Terminated |
| D-1266-2015 | 04-22-2015 | Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 539 Drums | Class II | Terminated |
| D-1259-2015 | 04-22-2015 | Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles. | Class II | Terminated |
| D-1267-2015 | 04-22-2015 | Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 1,002 Drums | Class II | Terminated |
| D-1258-2015 | 04-22-2015 | Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles. | Class II | Terminated |
| D-1274-2015 | 04-22-2015 | Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 68,066 Bottles | Class II | Terminated |
| D-1255-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 146,959 Bottles, B) 73,445 Bottles. | Class II | Terminated |
| D-1262-2015 | 04-22-2015 | Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 36,213 Bottles and B) 12,824 Bottles. | Class II | Terminated |
| D-1256-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 152,164 Bottles and B) 50,991 Bottles. | Class II | Terminated |
| D-1243-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 124,034 Bottles | Class II | Terminated |
| D-1244-2015 | 04-22-2015 | Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 149,924 Bottles and B) 35,012 Bottles | Class II | Terminated |
| D-1261-2015 | 04-22-2015 | Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles. | Class II | Terminated |
| D-1248-2015 | 04-22-2015 | Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons. | Class II | Terminated |
| D-1277-2015 | 04-22-2015 | Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 68,969 Bottles | Class II | Terminated |
| D-1269-2015 | 04-22-2015 | Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles. | Class II | Terminated |
| D-1275-2015 | 04-22-2015 | Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 162,743 Bottles and B) 14,205 Bottles | Class II | Terminated |
| D-1273-2015 | 04-22-2015 | Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 84,542 Bottles | Class II | Terminated |
| D-1245-2015 | 04-22-2015 | Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 5,910 Bottles | Class II | Terminated |
| D-1250-2015 | 04-22-2015 | Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles. | Class II | Terminated |
| D-1249-2015 | 04-22-2015 | Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 59,729 Bottles | Class II | Terminated |
| D-1265-2015 | 04-22-2015 | Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles. | Class II | Terminated |
| D-1253-2015 | 04-22-2015 | Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 407,958 Bottles | Class II | Terminated |
| D-1082-2015 | 04-21-2015 | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 Package NDCs: 47781-303-01 | Failed Dissolution Specification; 6 month time point | Alvogen, Inc / 13,392 bottles (100 count) | Class II | Terminated |
| D-1429-2015 | 04-20-2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | Subpotent Drug: Low out-of-specification potency result of the drug product. | Akorn, Inc. / 370 kits | Class III | Terminated |
| D-1035-2016 | 04-18-2015 | Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10. | Failed Impurities/Degradation Specifications | Valeant Pharmaceuticals North America LLC / 564,454 bottles | Class III | Terminated |
| D-1034-2016 | 04-18-2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10. Package NDCs: 0187-4100-10 | Failed Impurities/Degradation Specifications | Valeant Pharmaceuticals North America LLC / 6,321 bottles | Class III | Terminated |
| D-1116-2015 | 04-17-2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01. | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. | Valeant Pharmaceuticals North America LLC / 93,237 Bottles | Class II | Terminated |
| D-968-2015 | 04-16-2015 | Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle | Products failed the Antimicrobial Effectiveness Test. | Tarmac Products, Inc. / 16,248 bottles | Class II | Terminated |
| D-966-2015 | 04-16-2015 | Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle, | Products failed the Antimicrobial Effectiveness Test | Tarmac Products, Inc. / 41,743 bottles | Class II | Terminated |
| D-967-2015 | 04-16-2015 | Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) | Products failed the Antimicrobial Effectiveness Test | Tarmac Products, Inc. / 104,810 bottles | Class II | Terminated |
| D-1366-2015 | 04-15-2015 | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 561,390 Bottles | Class I | Terminated |
| D-1368-2015 | 04-15-2015 | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 561,390 Bottles | Class I | Terminated |
| D-1115-2015 | 04-15-2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06 | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point. | Sandoz, Inc / 1,023,430 units | Class III | Terminated |
| D-1365-2015 | 04-15-2015 | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 379,284 Bottles | Class I | Terminated |
| D-1367-2015 | 04-15-2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 200,688 Bottles | Class I | Terminated |
| D-1364-2015 | 04-15-2015 | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 717,336 Bottles | Class I | Terminated |
| D-1363-2015 | 04-15-2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Package NDCs: 63824-015-66; 63824-015-69 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 495036 Bottles | Class I | Terminated |
| D-1369-2015 | 04-15-2015 | Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5 Package NDCs: 72854-165-26; 63824-503-66; 63824-019-66 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 416,220 Bottles | Class II | Terminated |
| D-0486-2015 | 04-14-2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00. | Subpotent Drug: Flurandrenolide is subpotent. | Actavis Laboratories / 78,522 Cartons | Class III | Terminated |
| D-1356-2015 | 04-13-2015 | EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 48 bags | Class I | Terminated |
| D-1355-2015 | 04-13-2015 | HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 480 bags | Class I | Terminated |
| D-1358-2015 | 04-13-2015 | EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 264 bags | Class I | Terminated |
| D-1353-2015 | 04-13-2015 | oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 72 bags | Class I | Terminated |
| D-1354-2015 | 04-13-2015 | EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 36 bags | Class I | Terminated |
| D-1357-2015 | 04-13-2015 | HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 240 bags | Class I | Terminated |
| D-0972-2015 | 04-13-2015 | Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49 | Crystallization | Hospira Inc. / | Class II | Terminated |
| D-0973-2015 | 04-13-2015 | Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49 | Crystallization | Hospira Inc. / | Class II | Terminated |
| D-0971-2015 | 04-13-2015 | Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960 Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-0970-2015 | 04-13-2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-1088-2015 | 04-12-2015 | Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy. | Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL. | Stroheckers Inc Pharmacy / 365 vials | Class I | Terminated |
| D-1084-2015 | 04-10-2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 | Failed pH specification | Oasis Medical, Inc. / 9,731 cartons | Class III | Terminated |
| D-1077-2015 | 04-10-2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30 Package NDCs: 63736-013-30 | Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream. | Medtech Products, Inc. / 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples | Class III | Terminated |
| D-0490-2015 | 04-07-2015 | 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67 Package NDCs: 0409-7101-68; 0409-7101-66; 0409-7101-69; 0409-7101-67; 0409-7101-04; 0409-7101-02; 0409-7132-68; 0409-7132-66; 0409-7132-69; 0409-7132-67; 0409-7132-04; 0409-7132-02 | Lack of Sterility Assurance: The product has the potential to leak at the administrative port. | Hospira Inc. / 128,050 ADD-Vantage flexible containers | Class II | Terminated |
| D-1080-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 6,467 bottles/ blister cartons | Class III | Terminated |
| D-1129-2015 | 04-07-2015 | Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16 | Failed Impurities/Degradation Specifications | Akorn, Inc. / 424,174 bottles | Class II | Terminated |
| D-1081-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 5,352 bottles | Class III | Terminated |
| D-1130-2015 | 04-07-2015 | Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16 | Failed Impurities/Degradation Specifications | Akorn, Inc. / N/A | Class II | Terminated |
| D-1079-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 23,274 bottles/ blister cartons | Class III | Terminated |
| D-1085-2015 | 04-02-2015 | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25 Package NDCs: 0054-0140-25; 0054-0141-20; 0054-0141-25; 0054-0142-25 | Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. | Boehringer Ingelheim Roxane Inc / a) 575 Blister Packs, b) 12,802 Bottles | Class II | Completed |
| D-0992-2015 | 03-31-2015 | C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414 | Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL | Cody Laboratories, Inc. / 19,139 bottles | Class II | Terminated |
| D-0488-2015 | 03-26-2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90 | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell | Actavis Laboratories, FL, Inc. / 2,628 bottles | Class III | Terminated |
| D-1083-2015 | 03-26-2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20 | Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,363 UD Cartons | Class III | Terminated |
| D00432-2015 | 03-25-2015 | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. | Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point. | Qualitest Pharmaceuticals / 36,732 units | Class III | Terminated |
| D-0436-2015 | 03-25-2015 | GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01. Package NDCs: 23155-115-01; 23155-115-10; 23155-116-01; 23155-116-10; 23155-117-01; 23155-117-10 | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Heritage Pharmaceuticals, Inc. / 6,816 Bottles | Class II | Terminated |
| D-1209-2015 | 03-24-2015 | 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 402,284 bags | Class I | Terminated |
| D-1211-2015 | 03-24-2015 | Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02 Package NDCs: 0338-0117-02; 0338-0117-03; 0338-0117-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 58,932 bags | Class I | Terminated |
| D-1208-2015 | 03-24-2015 | 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 202,824 Bags | Class I | Terminated |
| D-0961-2015 | 03-24-2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045. Package NDCs: 51801-003-50; 51801-003-40; 51801-003-01; 0035180100; 0031747840; 17478-403-03 | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips. | Nomax Inc / 23,201 cartons | Class III | Terminated |
| D-0963-2015 | 03-24-2015 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123. | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips. | Nomax Inc / 62,691 cartons | Class III | Terminated |
| D-0962-2015 | 03-24-2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA. Package NDCs: 51801-004-40; 51801-004-01; 0035180100 | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips. | Nomax Inc / 5,514 cartons | Class III | Terminated |
| D-1210-2015 | 03-24-2015 | 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 18,324 bags | Class I | Terminated |
| D-1332-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4. | Presence of Particulate Matter | Mylan Institutional LLC / a) 35,197 vials; b) 21,302 vials | Class I | Terminated |
| D-1333-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5. | Presence of Particulate Matter | Mylan Institutional LLC / 2,455 vials | Class I | Terminated |
| D-1334-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1. | Presence of Particulate Matter | Mylan Institutional LLC / 10,094 vials | Class I | Terminated |
| D-0428-2015 | 03-23-2015 | Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Lack of Assurance of Sterility; increased complaints received for leaks | Baxter Healthcare Corp / 7444 containers | Class II | Terminated |
| D-0429-2015 | 03-23-2015 | 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility; increased complaints received for leaks | Baxter Healthcare Corp / 196,128 containers | Class II | Terminated |
| D-0425-2015 | 03-18-2015 | 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Baxter Healthcare Corp. / 597,498 units total | Class II | Terminated |
| D-0426-2015 | 03-18-2015 | 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Baxter Healthcare Corp. / 48,874 | Class II | Terminated |
| D-1331-2015 | 03-18-2015 | CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6. | Presence of Particulate Matter | Mylan Institutional LLC / 4,445 vials | Class I | Terminated |
| D-1328-2015 | 03-18-2015 | Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99. | Presence of Particulate Matter | Mylan Institutional LLC / a) 15,095 vials b) 300 vials | Class I | Terminated |
| D-0997-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 8,400 unit dose cups (20 mL each) | Class II | Terminated |
| D-1072-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 4 vials | Class II | Terminated |
| D-1075-2015 | 03-17-2015 | Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 70 vials | Class II | Terminated |
| D-1067-2015 | 03-17-2015 | Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 12 vials | Class II | Terminated |
| D-1070-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-0995-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 27,648 bottles (16 fl. oz. each) | Class II | Terminated |
| D-1074-2015 | 03-17-2015 | Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 56 vials | Class II | Terminated |
| D-1071-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 6 vials | Class II | Terminated |
| D-1069-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 15 vials | Class II | Terminated |
| D-1066-2015 | 03-17-2015 | Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 30 vials | Class II | Terminated |
| D-1068-2015 | 03-17-2015 | Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 43 vials | Class II | Terminated |
| D-1073-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-0996-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 326,666 bottles (16 fl. oz. each) | Class II | Terminated |
