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.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IMILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
Microbial Contamination of Non-Sterile Products.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IMILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
Microbial Contamination of Non-Sterile Products
- 2022-09-07FDA-DrugPadagis US LLCClass IITriamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- 2022-09-07FDA-DrugTsm Brands LLCClass IILuxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
- 2022-09-07FDA-DrugTsm Brands LLCClass IILuxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
- 2022-09-07FDA-DrugTeva Pharmaceuticals USA IncClass IINeomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
- 2022-09-07FDA-DrugLNK International, Inc.Class IIINighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
- 2022-09-07FDA-DrugAkorn, IncClass IIITimolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-09-07FDA-DrugFamily Dollar Stores, Llc.Class IIColgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
- 2022-08-31FDA-DrugMidlab IncorporatedClass IICorsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
- 2022-08-31FDA-DrugMidlab IncorporatedClass IIMaxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIVICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIQP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIMUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIQP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIHYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIMUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIREFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIQP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIREADY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IICLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIQP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIGS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
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