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
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 →
FDA Recall
Terminated
Historical recordClass III
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
by Teva Pharmaceuticals USA
- Reason
- Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
- Published
- November 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
by Ascent Pharmaceuticals, Inc.
- Reason
- Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
- Published
- November 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947
by Milbar Laboratories, Inc.
- Reason
- GMP Deviations
- Published
- November 25, 2020
- Distribution
- Product was distributed throughout the U…
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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