FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
by Teligent Pharma, Inc.
- Reason
- Superpotent and Subpotent; low and high assay results
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
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
by MPM Medical LLC
- Reason
- Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
- Published
- December 9, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
by InvaTech Pharma Solutions, LLC
- Reason
- Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
by Golden State Medical Supply Inc.
- Reason
- FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
- Published
- December 9, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
J F C International Inc
- Product
- YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 030…
- Reason
- Ama Natto (Sugar coated sweet beans) imported from Japan contains mold or the product may develop mold prior the best before date.
- Published
- December 9, 2020
- Distribution
- U.S distribution to the following: CA, W…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tucson Tamale Wholesale Company, LLC
- Product
- Tucson Tamale Blue Corn, Veggie & Cheese Tamales (2 Pack), 1…
- Reason
- Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tucson Tamale Wholesale Company, LLC
- Product
- Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (31…
- Reason
- Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0…
- Reason
- Pathogenic non-O157 E.coli STEC found during routine sampling by Michigan Department of Agriculture and Rural Development.
- Published
- December 9, 2020
- Distribution
- U.S. distribution to the following: AZ,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
by Teligent Pharma, Inc.
- Reason
- Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
by EYWA PHARMA INC
- Reason
- Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
by Heritage Pharmaceuticals Inc
- Reason
- Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
by Fusion Health and Vitality LLC
- Reason
- Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Fresenius Kabi USA, LLC
- Reason
- Cross Contamination with Other Products: trace amounts of octreotide found during testing
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Tablet/Capsule Specification
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
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.
by Sunstar Americas, Inc.
- Reason
- Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
- Published
- December 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Neil Jones Food Company
- Product
- Sysco Arrezzio 3/8" Petite Diced Tomatoes in Tomato Puree, #…
- Reason
- Recall due to presence of foreign material. Foreign object is made out of black and hard plastic.
- Published
- December 2, 2020
- Distribution
- Distributed in AZ and UT.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers
- Product
- Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), p…
- Reason
- Potential contamination with Salmonella.
- Published
- December 2, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
by Apotex Corp.
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- November 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
- Published
- November 25, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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