2,152 results found for contamination
Page 16 of 87
CIPLA
Class IITerminated
Esomeprazole 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...
Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
D-0181-2021January 6, 2021Warren, NJ
BASF Corporation
Class IICompleted
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfrie...
Reason: Cross contamination: the excipient was found to be contaminated with theophylline.
D-0149-2021December 23, 2020Florham Park, NJ
Fresenius Kabi USA, LLC
Class ITerminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
Reason: Cross Contamination with other products: trace amounts of lidocaine
D-0120-2021December 16, 2020Lake Zurich, IL
Lohxa LLC
Class ITerminated
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worc...
Reason: Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
D-0111-2021December 9, 2020Worcester, MA
MPM Medical LLC
Class ITerminated
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03
Reason: Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
D-0118-2021December 9, 2020Mesquite, TX
Sunstar Americas, Inc.
Class ICompleted
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
Reason: Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
D-0103-2021December 2, 2020Schaumburg, IL
Fresenius Kabi USA, LLC
Class IIITerminated
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
Reason: Cross Contamination with Other Products: trace amounts of octreotide found during testing
D-0105-2021December 2, 2020Lake Zurich, IL
4e Brands North America, Llc
Class ITerminated
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC...
Reason: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
D-0029-2021October 7, 2020San Antonio, TX
4e Brands North America, Llc
Class ITerminated
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distribut...
Reason: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
D-0031-2021October 7, 2020San Antonio, TX
4e Brands North America, Llc
Class ITerminated
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands North...
Reason: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
D-0030-2021October 7, 2020San Antonio, TX
Incredible Products, SA de CV
Class ITerminated
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 G...
Reason: Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
D-1587-2020September 30, 2020Guadalajara, N/A
Maison Terre, LLC
Class ITerminated
Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
Reason: Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sa...
D-1584-2020September 23, 2020North Little Rock, AR
Real Clean Distribuciones SA de CV
Class ITerminated
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Reason: Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufac...
D-1583-2020September 23, 2020Tlalnepantla De Baz, N/A
Broncolin, S.A. de C.V.
Class ITerminated
HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1...
Reason: Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
D-1578-2020September 23, 2020Ciudad De Mexico, N/A
AAA Cosmetica, SA de CV
Class ITerminated
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S...
Reason: Chemical Contamination: Product contains methanol.
D-1570-2020September 9, 2020Tlalnepantla, N/A
ROQUE PLAST, S.A. DE C.V.
Class IITerminated
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
Reason: CGMP Deviation: Potential contamination with undeclared methanol.
D-1559-2020September 9, 2020Atizapan De Zaragoza, N/A
Medichem S.A.
Class ITerminated
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joa...
Reason: Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
D-1534-2020September 2, 2020Barcelona, N/A
SCA Pharmaceuticals
Class ITerminated
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#: 700...
Reason: Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not c...
D-1550-2020September 2, 2020Windsor, CT
SCA Pharmaceuticals
Class ITerminated
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#: 70...
Reason: Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not c...
D-1551-2020September 2, 2020Windsor, CT
SCA Pharmaceuticals
Class ITerminated
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#: ...
Reason: Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not c...
D-1553-2020September 2, 2020Windsor, CT
SCA Pharmaceuticals
Class ITerminated
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#: 70...
Reason: Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not c...
D-1552-2020September 2, 2020Windsor, CT
Fresenius Kabi USA, LLC
Class ITerminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL ...
Reason: Cross Contamination with other products: trace amounts of lidocaine
D-1537-2020September 2, 2020Lake Zurich, IL
Itech 361 LLC
Class ITerminated
All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC C...
Reason: Chemical Contamination: Product contains undeclared methanol.