Drug Recalls

DuPont Nutrition USA, Inc

Class I Terminated

Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

Reason: Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).

D-0830-2021 September 29, 2021 Newark, DE

Grupo Asimex de Mexico SA de CV

Class I Terminated

Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blv...

Reason: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.

D-0795-2021 September 22, 2021 Ciudad De Mexico, N/A

China Gel Inc

Class II Ongoing

aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 7...

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

D-0790-2021 September 8, 2021 Arlington Heights, IL

China Gel Inc

Class II Ongoing

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) ...

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

D-0788-2021 September 8, 2021 Arlington Heights, IL

Global Sanitizers LLC

Class I Ongoing

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1

Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content a...

D-0781-2021 September 8, 2021 Las Vegas, NV

Global Sanitizers LLC

Class I Ongoing

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de...

Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content a...

D-0780-2021 September 8, 2021 Las Vegas, NV

China Gel Inc

Class II Ongoing

CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g)...

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

D-0789-2021 September 8, 2021 Arlington Heights, IL

SterRx, LLC

Class I Terminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

Reason: Non-Sterility: firm's third party lab confirmed microbial contamination.

D-0767-2021 September 1, 2021 Plattsburgh, NY

Aurobindo Pharma USA Inc.

Class II Terminated

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Mad...

Reason: Presence of Foreign Substance- Potential of metal contamination.

D-0719-2021 August 18, 2021 East Windsor, NJ

Scentsational Soaps & Candles Inc

Class I Terminated

Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01333 2