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-1261-2022 | 06-30-2022 | Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 47,905 syringes | Class II | Terminated |
| D-1260-2022 | 06-30-2022 | Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30,745 syringes | Class II | Terminated |
| D-1254-2022 | 06-30-2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3450 syringes | Class II | Terminated |
| D-1281-2022 | 06-30-2022 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,840 syringes | Class II | Terminated |
| D-1276-2022 | 06-30-2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 464,265 syringes | Class II | Terminated |
| D-1267-2022 | 06-30-2022 | Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 43,385 syringes | Class II | Terminated |
| D-1253-2022 | 06-30-2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3690 syringes | Class II | Terminated |
| D-1265-2022 | 06-30-2022 | Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 5495 syringes | Class II | Terminated |
| D-1250-2022 | 06-30-2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 19,060 syringes | Class II | Terminated |
| D-1257-2022 | 06-30-2022 | HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,570 syringes | Class II | Terminated |
| D-1280-2022 | 06-30-2022 | Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 85,300 syringes | Class II | Terminated |
| D-1270-2022 | 06-30-2022 | Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 59,520 syringes | Class II | Terminated |
| D-1264-2022 | 06-30-2022 | Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 37,310 syringes | Class II | Terminated |
| D-1248-2022 | 06-30-2022 | 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1380 syringes | Class II | Terminated |
| D-1278-2022 | 06-30-2022 | Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2210 syringes | Class II | Terminated |
| D-1272-2022 | 06-30-2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64,365 syringes | Class II | Terminated |
| D-1273-2022 | 06-30-2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1810 bags | Class II | Terminated |
| D-1246-2022 | 06-30-2022 | Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 13,340 syringes | Class II | Terminated |
| D-1274-2022 | 06-30-2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 75,630 syringes | Class II | Terminated |
| D-1245-2022 | 06-30-2022 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 163 bags | Class II | Terminated |
| D-1277-2022 | 06-30-2022 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6340 syringes | Class II | Terminated |
| D-1251-2022 | 06-30-2022 | EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 134,385 syringes | Class II | Terminated |
| D-1249-2022 | 06-30-2022 | Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2315 syringes | Class II | Terminated |
| D-1255-2022 | 06-30-2022 | HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 22,805 syringes | Class II | Terminated |
| D-1252-2022 | 06-30-2022 | Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 9410 bags | Class II | Terminated |
| D-1268-2022 | 06-30-2022 | Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 4620 syringes | Class II | Terminated |
| D-1258-2022 | 06-30-2022 | HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3740 syringes | Class II | Terminated |
| D-1269-2022 | 06-30-2022 | del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1765 bags | Class II | Terminated |
| D-1271-2022 | 06-30-2022 | Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 10,700 syringes | Class II | Terminated |
| D-1266-2022 | 06-30-2022 | Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 8985 syringes | Class II | Terminated |
| D-1275-2022 | 06-30-2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,930 syringes | Class II | Terminated |
| D-1247-2022 | 06-30-2022 | 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6900 syringes | Class II | Terminated |
| D-1256-2022 | 06-30-2022 | HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 12,900 syringes | Class II | Terminated |
| D-1262-2022 | 06-30-2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 184,370 syringes | Class II | Terminated |
| D-1263-2022 | 06-30-2022 | Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64,380 syringes | Class II | Terminated |
| D-1279-2022 | 06-30-2022 | 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 36,354 syringes | Class II | Terminated |
| D-1171-2022 | 06-29-2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 36 bottles | Class II | Terminated |
| D-1311-2022 | 06-29-2022 | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 6 boxes | Class II | Terminated |
| D-1299-2022 | 06-29-2022 | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 | Failed Dissolution Specifications | Eco Lips, Inc / 35,313 tubes | Class III | Terminated |
| D-1298-2022 | 06-29-2022 | Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 | Failed Dissolution Specifications | Eco Lips, Inc / 15,313 tubes | Class III | Terminated |
| D-1318-2022 | 06-29-2022 | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. Package NDCs: 63029-321-01; 63029-321-02; 0420371047 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 131 boxes | Class II | Terminated |
| D-1316-2022 | 06-29-2022 | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02. Package NDCs: 0065-1433-02; 0065-1433-07; 0065-1433-11; 0065143302 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 12 boxes | Class II | Terminated |
| D-1315-2022 | 06-29-2022 | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 16 boxes | Class II | Terminated |
| D-1323-2022 | 06-29-2022 | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc. Package NDCs: 0436-0672-16; 0436-0936-16; 0436-0946-16 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 113 bottles | Class II | Terminated |
| D-1327-2022 | 06-29-2022 | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued) Package NDCs: 67777-300-01; 67777-300-02; 67777-120-10 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / | Class II | Terminated |
| D-1326-2022 | 06-29-2022 | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16. Package NDCs: 67777-121-14; 67777-121-19; 67777-121-20; 67777-121-16; 67777-121-17; 67777-121-18; 67777-121-13; 67777-121-11; 67777-121-12; 67777-121-27; 67777-121-26; 67777-121-21; 67777-121-22; 67777-121-23; 67777-121-24 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 10 boxes | Class II | Terminated |
| D-1289-2022 | 06-29-2022 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30 Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Teva Pharmaceuticals USA Inc / 12354 cartons | Class II | Terminated |
| D-1312-2022 | 06-29-2022 | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. Package NDCs: 57896-443-66; 57896-443-12; 57896-443-55; 57896-443-05; 57896-443-01 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 45 boxes | Class II | Terminated |
| D-1319-2022 | 06-29-2022 | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4. Package NDCs: 11523-7268-3; 11523-7268-8; 11523-7268-7; 11523-7268-4; 11523-7268-9; 11523-7268-5; 11523-7234-1; 11523-7234-2; 11523-7234-3; 11523-7234-4; 11523-7234-5; 11523-7234-6; 11523-7234-9; 11523-7341-1; 11523-7341-2; 11523-4357-1; 11523-4357-3; 11523-4357-5; 11523-4357-2; 1152372340 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 67 bottles | Class II | Terminated |
| D-1282-2022 | 06-29-2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60. Package NDCs: 68462-405-60; 68462-405-30 | Failed Tablet/Capsule Specification : Capsule breakage | Glenmark Pharmaceuticals Inc., USA / 168936 bottles | Class III | Ongoing |
| D-1325-2022 | 06-29-2022 | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99. Package NDCs: 0487-5901-99 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 23 cartons | Class II | Terminated |
| D-1321-2022 | 06-29-2022 | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01. Package NDCs: 0065-8150-01; 0065-8150-03; 0065-8150-04; 0065-8150-07; 0006581500 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 1 box | Class II | Terminated |
| D-1305-2022 | 06-29-2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13. Package NDCs: 68462-840-13; 68462-841-13; 68462-842-13 | Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . | Glenmark Pharmaceuticals Inc., USA / 72288 units | Class II | Terminated |
| D-1324-2022 | 06-29-2022 | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 1 box | Class II | Terminated |
| D-1313-2022 | 06-29-2022 | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15. Package NDCs: 0065-0085-15; 0065-0085-38; 0065-0085-42; 0065-0085-52; 0065008515 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 12 boxes | Class II | Terminated |
| D-1317-2022 | 06-29-2022 | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. Package NDCs: 0065-4011-05; 0065-4011-06; 0065-4011-11; 0065401105 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 9 boxes | Class II | Terminated |
| D-1314-2022 | 06-29-2022 | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc. Package NDCs: 0065-0429-15; 0065-0429-21; 0065-0429-30; 0065-0429-36; 0065-0429-67; 0065042915; 0065042930 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 47 bottles | Class II | Terminated |
| D-1320-2022 | 06-29-2022 | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01. Package NDCs: 0065-0518-01; 3006505180 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 40 boxes | Class II | Terminated |
| D-1306-2022 | 06-29-2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13. Package NDCs: 68462-840-13; 68462-841-13; 68462-842-13 | Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . | Glenmark Pharmaceuticals Inc., USA / | Class II | Terminated |
| D-1322-2022 | 06-29-2022 | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 1 Jar | Class II | Terminated |
| D-1244-2022 | 06-28-2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716 Package NDCs: 21130-871-43; 21130-871-45; 0869-0871-72; 0869-0871-43; 0869-0871-45; 0869-0871-18; 0869-0871-99; 0869-0871-82; 53329-981-06; 53329-981-25; 61504-871-08; 61504-871-72; 61504-871-43; 41163-871-43; 41163-871-45; 0363-0871-43; 0363-0871-45; 0363-0871-50; 0363-0871-99; 49035-871-99; 49035-871-43; 49035-871-45 | Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol. | Vi-Jon, LLC / 3,421,032 bottles | Class II | Terminated |
| D-1291-2022 | 06-27-2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88. Package NDCs: 62756-796-83; 62756-796-88; 62756-796-08; 62756-796-13; 62756-796-18; 62756-797-83; 62756-797-88; 62756-797-08; 62756-797-13; 62756-797-18; 62756-798-83; 62756-798-88; 62756-798-08; 62756-798-13; 62756-798-18 | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. | SUN PHARMACEUTICAL INDUSTRIES INC / 9552 bottles | Class II | Terminated |
| D-1340-2022 | 06-27-2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864. | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Loud Muscle Science / 1500 10-count tins | Class II | Terminated |
| D-1339-2022 | 06-27-2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375. | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Loud Muscle Science / 2,495 60-count bottles | Class II | Terminated |
| D-1336-2022 | 06-27-2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375. | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Loud Muscle Science / 5,421 60-count bottles | Class I | Terminated |
| D-1338-2022 | 06-27-2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957. | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Loud Muscle Science / 500 4-count tins | Class I | Terminated |
| D-1337-2022 | 06-27-2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864. | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Loud Muscle Science / 1000 10-count tins | Class I | Terminated |
| D-1341-2022 | 06-27-2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957. | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Loud Muscle Science / 1500 4-count tins | Class II | Terminated |
| D-1286-2022 | 06-27-2022 | Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704 | Subpotent and Superpotent Drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy / 5 (60 gram) tubes | Class I | Terminated |
| D-1191-2022 | 06-24-2022 | Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3 Package NDCs: 59779-871-43; 59779-871-45; 59779-871-50; 59779-871-99 | Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol. | Vi-Jon, LLC / 36,840 bottles | Class II | Terminated |
| D-1169-2022 | 06-24-2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer. | Noven Pharmaceuticals Inc / 8,559 cartons | Class II | Ongoing |
| D-1427-2022 | 06-23-2022 | DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1395-2022 | 06-23-2022 | QP MOTION SICKNESS TABLET 8 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1453-2022 | 06-23-2022 | ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1455-2022 | 06-23-2022 | QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1459-2022 | 06-23-2022 | QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1385-2022 | 06-23-2022 | BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1414-2022 | 06-23-2022 | GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION 60CT SKU 999845 GS EFFERVESCENT ANTACID TABLET 36 CT SKU 913102 GUARDIAN ANTCD TBLT XTRA STGTH BRY 96 CT SKU 914109 GUARDIAN ANTCID TBLT REG STTH FRT 150 CT SKU 914726 GC ANTACID SUPREME CHERRY 12 FL OZ SKU 914112 GUARDIAN ANTD ULTR STRGTH 1000 FRT 72 CT SKU 902322 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1411-2022 | 06-23-2022 | SWAN CALAMINE LOTION 6 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1388-2022 | 06-23-2022 | BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU 914771 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1432-2022 | 06-23-2022 | AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1404-2022 | 06-23-2022 | DR SCHOLLS CLR AWAY LIQ WART REMVR 20CT SKU 998384 DR SCHOLLS CALLUS REMOVER PADS 4CT SKU 998431 DR SCHOLLS CORN REMOVERS 9CT SKU 998403 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1364-2022 | 06-23-2022 | AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1460-2022 | 06-23-2022 | MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1366-2022 | 06-23-2022 | Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU 2005444 Aveeno Baby Daily Moistue Lotion 8 OZ SKU 900016 Vaseline Mens Extra Strength Body and Face Lotion 10 OZ SKU 2003674 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1406-2022 | 06-23-2022 | ZARBEES NTRLS BABY CGH MUCUS GRP 2 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1447-2022 | 06-23-2022 | JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1407-2022 | 06-23-2022 | GOOD SENSE HEMORRHOID OINTMENT 2 OZ SKU 910325 GOOD SENSE HEMORRHOIDAL WIPES 48 CT SKU 902260 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1433-2022 | 06-23-2022 | ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SPOT TRTMT 1 OZ SKU 2096507 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1434-2022 | 06-23-2022 | VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1369-2022 | 06-23-2022 | Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1374-2022 | 06-23-2022 | FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1390-2022 | 06-23-2022 | READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1368-2022 | 06-23-2022 | Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Listerine Cool Mint Mouthwash 500 mL SKU 908223 Act Kids Bubble Gum Blowout Mouthwash 16.9 Fl OZ SKU 999935 Swan Ice Mint Antiseptic Mouth Rinse 8.5 OZ SKU 903150 Swan Mouthwash Cool Mint 1 Liter SKU 908466 Crest Mouthwash Pro Health Multi Protection Mint 1 Liter SKU 908123, Colgate Mouthwash Total Advanced Peppermint Blast 1 Liter SKU 903156 Listerine Total Care Freshmine 1 Liter SKU 900980 Listerine Ultra Clean Cool Mint 1 Liter SKU 901904 Listerine Mouthwash Freshburst 1 Liter SKU 903159 Listerine Mouthwas Original Amber 1 Liter SKU 908004 Listerine Mouthwash Coolmint 1 Liter SKU 908005 Swan Antiseptic Rinse Amber 1 Liter SKU 908465 Crest Scope Mouthwash All Day 1 Liter SKU 998269 Listerine Mouthwash Coolmint 95 Milliliters SKU 999752 Swan Fresh Mint Mouthwash 1 Liter SKU 999762 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown. | Class II | Ongoing |
| D-1454-2022 | 06-23-2022 | DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999542 AS PLUS MAX STRNGTH SINUS CONG N PN 20CT SKU 903334 GS DAYTIME COLD FLU RLF ORANGE 12FL OZ SKU 900576 NYQUIL SEVERE COLD FLU BERRY 8 FL OZ SKU 903759 NYQUIL ORGNL COLD AND FLU LQD 12FL OZ SKU 900207 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1429-2022 | 06-23-2022 | MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1446-2022 | 06-23-2022 | EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1365-2022 | 06-23-2022 | BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1397-2022 | 06-23-2022 | READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMBO PACK SKU 902373 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1405-2022 | 06-23-2022 | ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
