FDA Recall
Terminated
Historical recordClass II
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
by Medical Center Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- April 8, 2020
- Distribution
- Specific prescriptions to patients in TN
View recall →
FDA Recall
Terminated
Historical recordClass II
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
by Medical Center Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- April 8, 2020
- Distribution
- Specific prescriptions to patients in TN
View recall →
FDA Recall
Terminated
Historical recordClass II
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
by Medical Center Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- April 8, 2020
- Distribution
- Specific prescriptions to patients in TN
View recall →
FDA Recall
Terminated
Historical recordClass II
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
by Medical Center Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- April 8, 2020
- Distribution
- Specific prescriptions to patients in TN
View recall →
FDA Recall
Terminated
Historical recordClass II
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
by Medical Center Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- April 8, 2020
- Distribution
- Specific prescriptions to patients in TN
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Advanced Fresh Concepts Corp
- Product
- Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0…
- Reason
- Firm testing found Vibrio parahaemolyticus in cooked butterfly shrimp from Thailand.
- Published
- April 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
National Vitamin Company Inc
- Product
- Nature's Blend Folic Acid 1000 mcg Dietary Supplement, 1000-…
- Reason
- Customer reports of label error. Front panel states strength of 1000 mg although supplement fact is correct in stating 1000 mcg.
- Published
- April 8, 2020
- Distribution
- AZ. FL, GA, IL, MA, MI, MT, ND, NJ, NY,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Capstone, Inc
- Product
- ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G…
- Reason
- The firm was notified that the labeling does not include the word milk on the ingredient statement
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- SubPotent Drug: Low out-of-specification results for assay testing.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
- Published
- April 1, 2020
- Distribution
- TN and MO
View recall →
FDA Recall
Terminated
Historical recordClass III
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
by Grato Holdings, Inc.
- Reason
- Labeling mix-up - Indications on product label are incorrect.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Touchstone Essentials Organic Super Protein Vanilla Coconut…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Touchstone Essentials Super Greens Juice - Raspberry Apple;…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Pure Planet Organic Parasite Cleanse; Net Wt. 174g Glass Ja…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Springboard Green Power, Dietary Supplement; 240g Plastic B…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- RAWr! Life Organic Superfoods; Dietary Supplement; 300g Pla…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- L.O.V.E. Supermeal Vanilla Chai: 1320g Plastic Bottle, 660…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- L.O.V.E. Supermeal Original: 420g Plastic Bottle, 1396g Pla…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Purim Daily Fiber Blend - Original unflavored; 540g Plastic…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- 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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