Class I - Dangerous
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Spectra Medical Devices
Class I - Dangerous
Lack of Assurance of Sterility
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications