FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
by International Laboratories, Inc.
- Reason
- Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Clover Hill Dairy
- Product
- Clover Hill Dairy, Soft Ricotta
- Reason
- The firm had a deviation from the Standard of Procedure in the manufacture of Clover Hill Dairy, Soft Ricotta. The facility was temporarily storing whey in a raw milk silo, without cleaning and sanitizing the silo after raw milk use. The firm recalled the Clover Hill Dairy, Soft Ricotta.
- Published
- December 13, 2017
- Distribution
- One distributer located in Virginia as w…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Plow And Hearth
- Product
- 89291 Cashew Tower (Plow and Hearth Chocolate Covered Cashew…
- Reason
- Plow and Hearth was notified by a manufacture of their product labeled as chocolate covered cashews were actually salted peanuts. The firm has decided to initiate a recall of the product. (Undeclared Allergen Issue).
- Published
- December 13, 2017
- Distribution
- The firms sells their product via online…
View recall →
FDA Recall
Terminated
Historical recordClass II
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.
by EAI-JR286 INC
- Reason
- CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
by Mayne Pharma Inc
- Reason
- Failed Dissolution Specifications.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications; potential presence of broken tablets.
- Published
- December 6, 2017
- 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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