Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778…
Reason Subpotent drug
FDA Drug Recalls
454 recalls, newest first
Class II · Moderate risk Ongoing
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per…
Reason Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles…
Class II · Moderate risk Ongoing
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban…
Reason Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…
Class I · High risk Ongoing
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20…
Reason Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may…
Class I · High risk Ongoing
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators…
Reason Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II · Moderate risk Ongoing
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20…
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk Ongoing
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators…
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk Ongoing
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets…
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN…
Reason Presence of foreign substance: small metallic particles in chewable tablets.