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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1607-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1612-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1605-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1; and e) 1,000-count bottles, NDC 64727-3312-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1601-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64727-3307-1; and e) 1,000-count bottles, NDC 64727-3307-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1606-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1602-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1; and e) 1,000-count bottles, NDC 64727-3308-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1598-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299-1; and e) 1000-count bottles, NDC 64727-3299-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1596-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC 64727-3300-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1618-2020 | 08-25-2020 | Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1615-2020 | 08-25-2020 | Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1600-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3305-4; b) 60-count bottles, NDC 64727-3305-5; c) 90-count bottles, NDC 64727-3305-6; d) 100-count bottles, NDC 64727-3305-1; and e) 1,000-count bottles, NDC 64727-3305-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1604-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1617-2020 | 08-25-2020 | Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1603-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1608-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1610-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1616-2020 | 08-25-2020 | Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1619-2020 | 08-25-2020 | Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1599-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 64727-3303-1; e) 1,000-count bottles, NDC 64727-3303-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-0116-2021 | 08-25-2020 | V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ; | Lack of CGMPs: | Asiaticon, SA de CV / 111,500 units | Class II | Terminated |
| D-0117-2021 | 08-25-2020 | Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002 | Lack of CGMPs: | Asiaticon, SA de CV / 111,500 units | Class II | Terminated |
| D-1597-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-3302-1; and e) 1,000-count bottles, NDC 64727-3302-2; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1613-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1611-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-0001-2021 | 08-24-2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06 Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08 | Failed Dissolution Specifications | Strides Inc. / 11,280 bottles | Class II | Terminated |
| D-0013-2021 | 08-24-2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Teva Pharmaceuticals USA / 1,467,535 bottles | Class II | Terminated |
| D-1566-2020 | 08-24-2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | Sub-Potent Drug: Out of specification test results for potency (below specification). | Teva Pharmaceuticals USA / 38,487 bottles | Class II | Terminated |
| D-0012-2021 | 08-24-2020 | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Teva Pharmaceuticals USA / 103,940 bottles | Class II | Terminated |
| D-1544-2020 | 08-19-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01 Package NDCs: 76385-128-10; 76385-128-01; 76385-128-50; 76385-129-01; 76385-129-50 | CGMP Deviations | BAYSHORE PHARMACEUTICALS / 3984 bottles | Class II | Terminated |
| D-1543-2020 | 08-19-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10 Package NDCs: 76385-128-10; 76385-128-01; 76385-128-50; 76385-129-01; 76385-129-50 | CGMP Deviations | BAYSHORE PHARMACEUTICALS / 594 bottles | Class II | Terminated |
| D-1591-2020 | 08-18-2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0 | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV / 43,728 bottles | Class II | Terminated |
| D-1593-2020 | 08-18-2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01 | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv / 1,000 kg | Class II | Terminated |
| D-1592-2020 | 08-18-2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv / a)19,440 liters b) 25,917 gallon | Class II | Terminated |
| D-1590-2020 | 08-18-2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3 | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV / 55,560 bottles | Class II | Terminated |
| D-1584-2020 | 08-17-2020 | Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net | Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others. | Maison Terre, LLC / 670 bags | Class I | Terminated |
| D-1575-2020 | 08-17-2020 | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103. Package NDCs: 67457-153-00; 67457-153-03; 67457-153-99; 67457-153-09; 67457-153-18 | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC / 13,682 cartons | Class I | Terminated |
| D-1576-2020 | 08-17-2020 | Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103. Package NDCs: 67457-197-00; 67457-197-10 | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC / 1407 cartons | Class I | Terminated |
| D-1533-2020 | 08-14-2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01. Package NDCs: 0143-9246-01; 0143-9246-05 | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. / 97,890 vials | Class II | Terminated |
| D-0033-2021 | 08-14-2020 | Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16 | Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label. | Volu-Sol, Inc. / N/A | Class I | Terminated |
| D-0795-2021 | 08-14-2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. | Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content. | Grupo Asimex de Mexico SA de CV / 22,680 bottles | Class I | Terminated |
| D-0796-2021 | 08-14-2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. | CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol. | Grupo Asimex de Mexico SA de CV / N/A | Class II | Terminated |
| D-1572-2020 | 08-14-2020 | SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 9600 bottles | Class I | Terminated |
| D-1573-2020 | 08-14-2020 | Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 10,000 pens | Class I | Terminated |
| D-1571-2020 | 08-14-2020 | SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 9600 bottles | Class I | Terminated |
| D-1574-2020 | 08-14-2020 | Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 122,500 individual wipe packets | Class I | Terminated |
| D-1508-2020 | 08-10-2020 | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37 | Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg | Lannett Company, Inc. / N/A | Class II | Terminated |
| D-1542-2020 | 08-10-2020 | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | Failed Impurity /Degradation Specifications | Par Pharmaceutical Inc. / 11,347 bottles | Class II | Terminated |
| D-1535-2020 | 08-10-2020 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05. Package NDCs: 65862-419-20; 65862-419-01; 65862-419-05; 65862-419-99; 65862-420-20; 65862-420-01; 65862-420-05; 65862-420-99 | Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). | Aurobindo Pharma USA Inc. / 5748 bottles | Class II | Terminated |
| D-1507-2020 | 08-10-2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75 Package NDCs: 0024-5150-10; 0024-5154-11; 0024-5152-11; 0024-5151-75; 0024-5155-74; 0024-5153-74 | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. | Sanofi-Aventis U.S. LLC / 7451 vials | Class II | Ongoing |
| D-1557-2020 | 08-07-2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220 | Subpotent drug | Santa Cruz Biotechnology, Inc / 14,238 bottles | Class II | Terminated |
| D-1564-2020 | 08-07-2020 | Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts / 2880 boxes | Class II | Terminated |
| D-1563-2020 | 08-07-2020 | Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030) | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts / 340,000 packs | Class II | Terminated |
| D-0662-2022 | 08-06-2020 | Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 3 bottles | Class II | Terminated |
| D-0667-2022 | 08-06-2020 | Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-0659-2022 | 08-06-2020 | Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-1545-2020 | 08-06-2020 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India | Failed Tablet/Capsule Specification; complaint of bulging tablet | Hetero Labs Limited (Unit V) / 43,512 bottles | Class II | Terminated |
| D-0663-2022 | 08-06-2020 | Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 8 bags | Class II | Terminated |
| D-0658-2022 | 08-06-2020 | Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-0657-2022 | 08-06-2020 | Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 4 bags | Class II | Terminated |
| D-0664-2022 | 08-06-2020 | Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 3 bags | Class II | Terminated |
| D-0666-2022 | 08-06-2020 | Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 5 syringes | Class II | Terminated |
| D-0660-2022 | 08-06-2020 | Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 2 vials | Class II | Terminated |
| D-0656-2022 | 08-06-2020 | Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 2 bags | Class II | Terminated |
| D-0665-2022 | 08-06-2020 | Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-1587-2020 | 08-06-2020 | Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX. | Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol. | Incredible Products, SA de CV / N/A | Class I | Terminated |
| D-0661-2022 | 08-06-2020 | Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 5 vials | Class II | Terminated |
| D-1494-2020 | 08-04-2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16 Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | Subpotent drug: Out of specification for assay at the 15-month test interval. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 7416 bottles | Class II | Terminated |
| D-1559-2020 | 08-04-2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2 | CGMP Deviation: Potential contamination with undeclared methanol. | ROQUE PLAST, S.A. DE C.V. / 311,038 bottles | Class II | Terminated |
| D-1500-2020 | 08-04-2020 | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125 | cGMP Deviations. | Eosera, Inc. / 43,424 bottles | Class II | Terminated |
| D-1498-2020 | 08-04-2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8 | cGMP Deviations. | Eosera, Inc. / 45,673 bottles | Class II | Terminated |
| D-1501-2020 | 08-04-2020 | Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5 | cGMP Deviations. | Eosera, Inc. / 15229 bottles | Class II | Terminated |
| D-1499-2020 | 08-04-2020 | Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2 | cGMP Deviations. | Eosera, Inc. / 125,874 bottles | Class II | Terminated |
| D-1512-2020 | 08-03-2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007 | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. | Ultra Seal Corporation / 4,666,355 packets | Class III | Terminated |
| D-1561-2020 | 08-03-2020 | Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery | Labeling Not Elsewhere Classified: Product labeled to contain methanol. | Leiper's Fork Distillery / 1996 gallons | Class II | Terminated |
| D-1513-2020 | 08-03-2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139, | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. | Ultra Seal Corporation / 701,735 packets | Class III | Terminated |
| D-1555-2020 | 07-31-2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico. | cGMP deviations | Laboratorios Jaloma S.A. de C.V. / 211,875 bottles | Class II | Terminated |
| D-1541-2020 | 07-31-2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8 Package NDCs: 10742-8902-1 | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not. | The Mentholatum Company / 31,732 Blister Packs | Class III | Terminated |
| D-1539-2020 | 07-30-2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21 | Discoloration and Presence of Foreign Substance | Ecolab Inc / 305 drums | Class II | Terminated |
| D-0081-2021 | 07-30-2020 | Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 19,992 bottles | Class II | Ongoing |
| D-0079-2021 | 07-30-2020 | Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 2,760 bottles | Class II | Ongoing |
| D-0078-2021 | 07-30-2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 1,441,548 bottles | Class II | Ongoing |
| D-0080-2021 | 07-30-2020 | Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 27,000 bottles | Class II | Ongoing |
| D-0082-2021 | 07-30-2020 | NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 4,598,788 bottles | Class II | Ongoing |
| D-1551-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 366 Containers | Class I | Terminated |
| D-1550-2020 | 07-29-2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 1,097 Containers | Class I | Terminated |
| D-1552-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 1,527 Containers | Class I | Terminated |
| D-1553-2020 | 07-29-2020 | Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 362 Containers | Class I | Terminated |
| D-1495-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | SCA Pharmaceuticals / 3,932 bags | Class II | Terminated |
| D-1529-2020 | 07-27-2020 | Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1523-2020 | 07-27-2020 | Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1530-2020 | 07-27-2020 | Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1531-2020 | 07-27-2020 | Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1525-2020 | 07-27-2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1532-2020 | 07-27-2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1521-2020 | 07-27-2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1548-2020 | 07-27-2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020 | cGMP deviations | RESOURCE RECOVERY & TRADING LLC / 17,280 bottles | Class II | Completed |
| D-1517-2020 | 07-27-2020 | Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1519-2020 | 07-27-2020 | Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1528-2020 | 07-27-2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1524-2020 | 07-27-2020 | Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
