Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-11-08FDA-DrugSCA Pharmaceuticals, LLCClass IISUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
Lack Of Assurance Of Sterility.
- 2017-11-08FDA-DrugKiriko, LLC.Class IIA1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- 2017-11-08FDA-DrugPrecision Dose Inc.Class IIICarbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Subpotent Drug: low out of specification results.
- 2017-11-08FDA-DrugSanofi-Aventis U.S. LLCClass IIIClofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
- 2017-11-08FDA-DrugAVKARE Inc.Class IIDuloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
- 2017-11-01FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIFluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Cross contamination with other products: traces of Dapsone were found in the finished product.
- 2017-11-01FDA-DrugVi-Jon, Inc.Class IIIEquate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC # 0363001726, UPC # 049022889125
Failed Stability Specifications
- 2017-11-01FDA-DrugAidarex Pharmaceuticals LLCClass IIIENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
- 2017-11-01FDA-DrugTeva Pharmaceuticals USAClass IIIMethylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Failed Dissolution Specifications: Low out of specification results for dissolution.
- 2017-11-01FDA-DrugWockhardt Usa Inc.Class IIIEnalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-02
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03
Subpotent Drug
- 2017-11-01FDA-DrugAbbVie Inc.Class IIIAndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- 2017-11-01FDA-DrugAbbVie Inc.Class IIIAndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- 2017-11-01FDA-DrugVitilityClass IMAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- 2017-11-01FDA-DrugLucky Mart Inc.Class IPIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
- 2017-11-01FDA-DrugBaxter Healthcare CorporationClass IIntralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
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