FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass I
MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.
by New Life Nutritional Center
- Reason
- Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
- Published
- December 31, 2014
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass I
New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040.
by New Life Nutritional Center
- Reason
- Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
- Published
- December 31, 2014
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: January 13, 2017Historical recordClass II
MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
by Chaotic Labz
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
- Published
- December 31, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.
by Hospira Inc.
- Reason
- Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
- Published
- December 31, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 6, 2015Historical recordClass I
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
by Pharmacy Creations
- Reason
- Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
- Published
- December 31, 2014
- Distribution
- Directly to patients and physicians in F…
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FDA Recall
TerminatedTerminated: July 6, 2015Historical recordClass I
Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
by Pharmacy Creations
- Reason
- Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
- Published
- December 31, 2014
- Distribution
- Directly to patients and physicians in F…
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FDA Recall
TerminatedTerminated: July 6, 2015Historical recordClass I
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
by Pharmacy Creations
- Reason
- Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
- Published
- December 31, 2014
- Distribution
- Directly to patients and physicians in F…
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FDA Recall
TerminatedTerminated: July 6, 2015Historical recordClass I
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
by Pharmacy Creations
- Reason
- Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
- Published
- December 31, 2014
- Distribution
- Directly to patients and physicians in F…
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FDA Recall
TerminatedTerminated: August 13, 2015Historical recordClass III
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
by Wockhardt Usa Inc.
- Reason
- Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass II
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
by Hospira Inc.
- Reason
- Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 21, 2015Historical recordClass III
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
by Eisai Inc
- Reason
- Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 28, 2015Historical recordClass II
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 1, 2015Historical recordClass II
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
by American Health Packaging
- Reason
- Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 25, 2017Historical recordClass II
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
- Published
- December 24, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 8, 2015Historical recordClass III
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
by CareFusion 213, LLC
- Reason
- Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
- Published
- December 17, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 12, 2014Historical recordClass II
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 12, 2014Historical recordClass II
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 12, 2014Historical recordClass II
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass II
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility; improperly crimped fliptop vials
- Published
- December 17, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 16, 2015Historical recordClass II
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
- Published
- December 17, 2014
- 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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