FDA Recall
Terminated
Historical recordClass II
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
by VistaPharm, Inc.
- Reason
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
by VistaPharm, Inc.
- Reason
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
by Fresenius Kabi USA, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Roland Foods, LLC.
- Product
- Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 O…
- Reason
- Product quality issue. Through sampling, FDA revealed the presence of non-pathogenic Gram Positive Rods (microorganisms).
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Burgundy and Bronze Metal Basket
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- The Classic Basket #6013
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- California Wine Crate Basket #990
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Napa and Sonoma Duet Basket #973
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Alfasi Chardonnay Kosher Selection Basket #847
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Alfasi Kosher Trio Basket #812
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Alfasi Cabernet Kosher Selection Basket #810
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Houdini Napa Valley Collection Basket #766
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Vintners Path Cabernet Seasons Greetings Basket #763
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Stags Leap Winery Collection Basket #752
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Vintners Path Merlot Seasons Greetings Basket #724
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 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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