Category
Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2020-09-30FDA-DrugPerrigo Company PLCClass IIAlbuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01
Defective Delivery System: Sustained trend of failure to dispense complaints.
- 2020-09-30FDA-DrugNanomateriales Sa De CvClass IIZanilast+ 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.
- 2020-09-30FDA-DrugNanomateriales Sa De CvClass IIZanilast+ 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.
- 2020-09-30FDA-DrugGRUPO YACANA MEXICO SAS DE CVClass IIYacana 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
- 2020-09-30FDA-DrugGRUPO YACANA MEXICO SAS DE CVClass IIYacana 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
- 2020-09-30FDA-DrugIncredible Products, SA de CVClass IIncredible 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.
- 2020-09-30FDA-DrugCORGIOMED LLCClass ILeafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
- 2020-09-23FDA-DrugRLC Labs Inc.Class INature 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
- 2020-09-23FDA-DrugRLC Labs Inc.Class INature 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
- 2020-09-23FDA-DrugRLC Labs Inc.Class INature 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
- 2020-09-23FDA-DrugRLC Labs Inc.Class INature 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
- 2020-09-23FDA-DrugRLC Labs Inc.Class INature 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
- 2020-09-23FDA-DrugRLC Labs Inc.Class IWP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
Subpotent Drug: FDA analysis found product to be subpotent
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IIWP 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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
- 2020-09-23FDA-DrugRLC Labs Inc.Class IINature-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.
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