FDA Recall
Terminated
Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mountain Rose Inc. dba Mountain Rose Herbs
- Product
- Kudzu Root (Pueraria montana var. lobata), This product was…
- Reason
- Salmonella
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01
by Avet Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
by Avet Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
by Avet Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
by Avet Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 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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