FDA Recall
Terminated
Historical recordClass II
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hometown Food Company
- Product
- Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper…
- Reason
- Product may be contaminated with Salmonella
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Subpotent Drug.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
by Teva Pharmaceuticals USA
- Reason
- Subpotent Drug.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
by American Health Packaging
- Reason
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
by Camber Pharmaceuticals Inc
- Reason
- CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
by Camber Pharmaceuticals Inc
- Reason
- CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- Published
- March 27, 2019
- 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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