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-1106-2017 | 07-17-2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1098-2017 | 07-17-2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 105 creams | Class III | Terminated |
| D-1110-2017 | 07-17-2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1104-2017 | 07-17-2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1099-2017 | 07-17-2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 73 balms | Class III | Terminated |
| D-1108-2017 | 07-17-2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1144-2017 | 07-17-2017 | New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected] | Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. | BESTHERBS COFFEE LLC / 6,250 packets | Class I | Terminated |
| D-1054-2017 | 07-17-2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831 | Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis. | Vi-Jon, Inc. / 101,244 bottles | Class II | Terminated |
| D-1100-2017 | 07-17-2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 373 creams | Class III | Terminated |
| D-1109-2017 | 07-17-2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1016-2017 | 07-14-2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1012-2017 | 07-14-2017 | fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1010-2017 | 07-14-2017 | fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1000-2017 | 07-14-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 130 bags | Class II | Terminated |
| D-1015-2017 | 07-14-2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1034-2017 | 07-14-2017 | fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1027-2017 | 07-14-2017 | PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1022-2017 | 07-14-2017 | NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1074-2017 | 07-14-2017 | Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12 | Lack of Sterility Assurance. | Cantrell Drug Company / 46078 syringes | Class II | Terminated |
| D-1009-2017 | 07-14-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1069-2017 | 07-14-2017 | Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 18015 syringes | Class II | Terminated |
| D-1001-2017 | 07-14-2017 | ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 108 bags | Class II | Terminated |
| D-1031-2017 | 07-14-2017 | PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1025-2017 | 07-14-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1018-2017 | 07-14-2017 | ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1013-2017 | 07-14-2017 | fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-0999-2017 | 07-14-2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 220 bags | Class II | Terminated |
| D-1008-2017 | 07-14-2017 | fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1064-2017 | 07-14-2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 49666 syringes | Class II | Terminated |
| D-1079-2017 | 07-14-2017 | Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 28779 syringes | Class II | Terminated |
| D-1062-2017 | 07-14-2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 25529 syringes | Class II | Terminated |
| D-1076-2017 | 07-14-2017 | Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03 | Lack of Sterility Assurance. | Cantrell Drug Company / 6210 syringes | Class II | Terminated |
| D-1019-2017 | 07-14-2017 | EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1078-2017 | 07-14-2017 | Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 120856 syringes | Class II | Terminated |
| D-1014-2017 | 07-14-2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1066-2017 | 07-14-2017 | Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16 | Lack of Sterility Assurance. | Cantrell Drug Company / 21080 syringes | Class II | Terminated |
| D-1030-2017 | 07-14-2017 | PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1029-2017 | 07-14-2017 | PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1004-2017 | 07-14-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 2 bags | Class II | Terminated |
| D-1072-2017 | 07-14-2017 | Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18 | Lack of Sterility Assurance. | Cantrell Drug Company / 3039 bags | Class II | Terminated |
| D-1026-2017 | 07-14-2017 | PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1020-2017 | 07-14-2017 | NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1011-2017 | 07-14-2017 | fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1065-2017 | 07-14-2017 | Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 75840 syringes | Class II | Terminated |
| D-1067-2017 | 07-14-2017 | Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45 | Lack of Sterility Assurance. | Cantrell Drug Company / 5245 syringes | Class II | Terminated |
| D-1063-2017 | 07-14-2017 | Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45 | Lack of Sterility Assurance. | Cantrell Drug Company / 7656 syringes | Class II | Terminated |
| D-1070-2017 | 07-14-2017 | Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18 | Lack of Sterility Assurance. | Cantrell Drug Company / 8928 bags | Class II | Terminated |
| D-1002-2017 | 07-14-2017 | Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 120 bags | Class II | Terminated |
| D-1071-2017 | 07-14-2017 | Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18 | Lack of Sterility Assurance. | Cantrell Drug Company / 1718 bags | Class II | Terminated |
| D-1061-2017 | 07-14-2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12 | Lack of Sterility Assurance. | Cantrell Drug Company / 24638 syringes | Class II | Terminated |
| D-1032-2017 | 07-14-2017 | Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1007-2017 | 07-14-2017 | BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1005-2017 | 07-14-2017 | BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1028-2017 | 07-14-2017 | PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1073-2017 | 07-14-2017 | Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13 | Lack of Sterility Assurance. | Cantrell Drug Company / 2761 bags | Class II | Terminated |
| D-1075-2017 | 07-14-2017 | Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222 | Lack of Sterility Assurance. | Cantrell Drug Company / 40081 syringes | Class II | Terminated |
| D-1068-2017 | 07-14-2017 | Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12 | Lack of Sterility Assurance. | Cantrell Drug Company / 57430 syringes | Class II | Terminated |
| D-1023-2017 | 07-14-2017 | PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1006-2017 | 07-14-2017 | BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1017-2017 | 07-14-2017 | Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1003-2017 | 07-14-2017 | MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 40 bags | Class II | Terminated |
| D-1033-2017 | 07-14-2017 | Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1021-2017 | 07-14-2017 | NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1024-2017 | 07-14-2017 | PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1089-2017 | 07-12-2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012 | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 40,978 unit dose cups | Class III | Terminated |
| D-0001-2018 | 07-12-2017 | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10. | CGMP Deviations: Firm failed to control impurity for color change at the API stage. | Pfizer Inc. / 32,276 10 mL vials | Class III | Terminated |
| D-1088-2017 | 07-12-2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701. | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 541,900 unit dose cups (5,419 trays) | Class III | Terminated |
| D-1090-2017 | 07-12-2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014 | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 101,952 15 mL unit dose cups | Class III | Terminated |
| D-1040-2017 | 07-12-2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025 | CGMP Deviations | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / 120 vials | Class II | Terminated |
| D-1038-2017 | 07-11-2017 | Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. Package NDCs: 55111-229-30; 55111-229-90; 55111-229-01; 55111-229-05; 55111-230-30; 55111-230-90; 55111-230-01; 55111-230-05; 55111-231-30; 55111-231-90; 55111-231-01; 55111-231-05; 55111-274-30; 55111-274-90; 55111-274-01; 55111-274-05 | Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. | Dr. Reddy's Laboratories, Inc. / 544 bottles | Class III | Terminated |
| D-0972-2017 | 07-06-2017 | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38 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: Bags have the potential to leak. | Baxter Healthcare Corporation / 54,528 bags | Class II | Terminated |
| D-0973-2017 | 07-06-2017 | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38 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: Bags have the potential to leak. | Baxter Healthcare Corporation / 295,200 bags | Class II | Terminated |
| D-0980-2017 | 07-06-2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01 | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point | Hospira Inc., A Pfizer Company / 701 vials | Class III | Terminated |
| D-0957-2017 | 07-06-2017 | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, 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 | Lack of Assurance of Sterility: Customer complaints for leaking bags. | Baxter Healthcare Corporation / 131,904 bags | Class II | Terminated |
| D-1084-2017 | 07-05-2017 | ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0 | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | HARDCORE FORMULATIONS / 1490 bottles | Class I | Terminated |
| D-1085-2017 | 07-05-2017 | D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1 | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | HARDCORE FORMULATIONS / 1440 bottles | Class I | Terminated |
| D-1037-2017 | 07-05-2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59. | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC. | Precision Dose Inc. / 480 (5mL) unit dose cups | Class II | Terminated |
| D-0983-2017 | 06-29-2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56 | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA / 25264 bottles | Class III | Terminated |
| D-0984-2017 | 06-29-2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56 | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA / 196275 bottles | Class III | Terminated |
| D-0998-2017 | 06-28-2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02 | Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information. | Valeant Pharmaceuticals North America LLC / 844 bottles | Class III | Terminated |
| D-0944-2017 | 06-28-2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01. Package NDCs: 0135-0598-01; 0135-0598-02; 0135-0599-01; 0135-0599-02; 0135-0601-01; 0135-0601-02 | Presence of Foreign Substance: possibility of the presence of metal in the product. | GSK Consumer Healthcare / 15,708 tubes | Class II | Terminated |
| D-1053-2017 | 06-26-2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01 | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. / 9945 cases | Class II | Terminated |
| D-1052-2017 | 06-26-2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50 | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. / 6150 cases | Class II | Terminated |
| D-0991-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0996-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0990-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0993-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0988-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0985-2017 | 06-26-2017 | Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0989-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0992-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0997-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0987-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0994-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0986-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0995-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-1132-2017 | 06-23-2017 | Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 16 bottles | Class II | Terminated |
| D-1130-2017 | 06-23-2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 2608 vials | Class II | Terminated |
| D-1131-2017 | 06-23-2017 | Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 19 bottles | Class II | Terminated |
| D-1133-2017 | 06-23-2017 | Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 2 bottles | Class II | Terminated |
