FDA Recall
Terminated
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
by SCA Pharmaceuticals
- Reason
- CGMP Deviations
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
by SCA Pharmaceuticals
- Reason
- CGMP Deviations
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
by SCA Pharmaceuticals
- Reason
- CGMP Deviations
- Published
- May 11, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Elegant Foods, LLC
- Product
- elegant foods Holiday Macaron Variety, Case of 100. 537 Atl…
- Reason
- Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
- Published
- May 11, 2022
- Distribution
- WI
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Elegant Foods, LLC
- Product
- elegant foods Macaron Variety B, Case of 100. 537 Atlas Ave…
- Reason
- Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
- Published
- May 11, 2022
- Distribution
- WI
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Elegant Foods, LLC
- Product
- elegant foods Macaron Variety A, Case of 100. 537 Atlas Ave…
- Reason
- Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
- Published
- May 11, 2022
- Distribution
- WI
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Elegant Foods, LLC
- Product
- elegant foods Raspberry Macaron, Case of 100. 537 Atlas Ave…
- Reason
- Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
- Published
- May 11, 2022
- Distribution
- WI
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Elegant Foods, LLC
- Product
- elegant foods Passion Fruit Mango Macaron, Case of 100. 537…
- Reason
- Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
- Published
- May 11, 2022
- Distribution
- WI
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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