FDA Recall
Terminated
Historical recordClass II
Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0
by Odan Laboratories Ltd
- Reason
- Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
by Sun Pharmaceutical Industries, Inc.
- Reason
- Lack Of Assurance Of Sterility
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
by Hetero Labs, Ltd. - Unit III
- Reason
- Presence of foreign substance: metallic razor blade was found in one bottle.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
by AVKARE Inc.
- Reason
- Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
by PharMEDium Services, LLC
- Reason
- Superpotent Drug
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
by Shionogi Inc.
- Reason
- Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
by SHISEIDO AMERICA INC.
- Reason
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
by SHISEIDO AMERICA INC.
- Reason
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
by SHISEIDO AMERICA INC.
- Reason
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
by SHISEIDO AMERICA INC.
- Reason
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
by SHISEIDO AMERICA INC.
- Reason
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fieldbrook Foods Corporation
- Product
- Ice Cream Variety Packs containing Sandwiches, Bars, and Con…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fieldbrook Foods Corporation
- Product
- RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fieldbrook Foods Corporation
- Product
- Chocolate Covered Vanilla Ice Cream Bars packaged under the…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fieldbrook Foods Corporation
- Product
- Orange Cream Ice Cream Bars sold under the following labels:…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Rio Pacific Foods Deluxe BBQ Sauce; 3.78 litre; Produced in…
- Reason
- A plastic foreign object was inadvertently introduced into the product stream. The firm is recalling product as not all plastic has been accounted.
- Published
- January 24, 2018
- 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.
Read the full medical disclaimer.