Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass ICord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass IHappy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- 2021-01-06FDA-DrugFresenius Kabi USA, LLCClass IIKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Presence of Particulate Matter - found in reserve sample vials at the firm.
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugStrides Pharma Inc.Class IIINDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Failed Moisture Limits
- 2021-01-06FDA-DrugAscend Laboratories LLCClass IIAscend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
Failed Impurity/Degradation Specifications
- 2021-01-06FDA-DrugAscend Laboratories LLCClass IIAscend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Failed Impurity/Degradation Specifications
- 2021-01-06FDA-DrugImprimis NJOF, LLCClass IIDexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
- 2021-01-06FDA-DrugUS Compounding IncClass IIINeostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05
Labelling: Missing label.
- 2020-12-30FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIHydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
- 2020-12-30FDA-DrugFresenius Kabi USA, LLCClass IISensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
- 2020-12-30FDA-DrugSCA Pharmaceuticals, Inc.Class IIVasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
Subpotent drug.
- 2020-12-30FDA-DrugAkebia Therapeutics dba Keryx Biopharmaceutials, IncClass IIAuryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01
CGMP Deviations
- 2020-12-23FDA-DrugHikma Pharmaceuticals USA Inc.Class IISodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
- 2020-12-23FDA-DrugAVKARE Inc.Class ITraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
- 2020-12-23FDA-DrugAVKARE Inc.Class IISildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
- 2020-12-23FDA-DrugCIPLAClass IIAzacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
cGMP deviations: Vials may not be sealed correctly affecting sterility.
- 2020-12-23FDA-DrugSimex Logistics SA de CVClass IILavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897
Subpotent drug
- 2020-12-23FDA-DrugSimex Logistics SA de CVClass IIUVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2
Subpotent drug
- 2020-12-23FDA-DrugSimex Logistics SA de CVClass IIHealth & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. smxcontact@simex-logistics.com Barcode: 6 18149 21988 9
Subpotent drug
- 2020-12-23FDA-DrugSimex Logistics SA de CVClass IICitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01
Subpotent drug
- 2020-12-23FDA-DrugSimex Logistics SA de CVClass II+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.
Subpotent drug
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIAthlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IITopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIBest Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIRiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIKroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIKroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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