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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.;…
- 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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Single-serve plastic pack: Newman's Own Lite Sesame Ginger;…
- 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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Single-serve plastic packet Italian Dressing; Case packing:…
- 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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- plastic cup with foil seal: House Recipe Ranch Dressing & D…
- 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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- plastic cup with foil seal: House Recipe Bleu Cheese Dressi…
- 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.
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