FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
by Shionogi Inc.
- Reason
- Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
by Shionogi Inc.
- Reason
- Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
by Hospira Inc., A Pfizer Company
- Reason
- Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B99187, BREADER X1, NET WT 50 LBS, Manufactured By: Newly We…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B94797, BREADER X1@, NET WT 40 LBS, Manufactured By: Newly W…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B94412, BREADER X1@, NET WT 50 LBS, Manufactured By: Newly W…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B94128, BREADER X1, NET WT 50 LBS, Manufactured By: Newly We…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B94110, BREADER X1, NET WT 50 LBS, Manufactured By: Newly We…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B94109, BREADER X1@, NET WT 50 LBS, Manufactured By: Newly W…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B93836, BREADER X1, NET WT 25 LBS, Manufactured By: Newly We…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B93709, BREADER X1@, NET WT 40 LBS, Manufactured By: Newly W…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- B93706, BREADER X5, NET WT 50 LBS, Manufactured By: Newly We…
- Reason
- Product may contain undeclared milk.
- Published
- July 26, 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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