FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
by Aurobindo Pharma USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Foods
- Product
- NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A D…
- Reason
- Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms).
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Two Little Guys Company
- Product
- Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Di…
- Reason
- Joe Chips Sour Cream & Toasted Onion Retro Potato Chips contains a seasoning with a milk powder ingredient that may be contaminated with Salmonella although firm testing has not revealed the presence of the bacteria.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
by Apotex Inc.
- Reason
- Superpotent Drug: Product may not meet specifications throughout shelf life.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
by Aurobindo Pharma USA Inc
- Reason
- Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
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
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
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
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), 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
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), 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
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
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
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
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 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), 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
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
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
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
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
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 →
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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