FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EMILIA FOODS SRL
- Product
- Good & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Ke…
- Reason
- Good and Gather Four Cheese Gnocchi may contain foreign material.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
- Published
- January 27, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
by Complete Pharmacy and Medical Solutions, LLC.
- Reason
- CGMP deviations: Lack of potency testing.
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
by Complete Pharmacy and Medical Solutions, LLC.
- Reason
- CGMP deviations: Lack of potency testing.
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
by Complete Pharmacy and Medical Solutions, LLC.
- Reason
- CGMP deviations: Lack of potency testing.
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
by Complete Pharmacy and Medical Solutions, LLC.
- Reason
- CGMP deviations: Lack of potency testing.
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
by Allergan, PLC.
- Reason
- Labeling: Missing instructions for use insert
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)
by Genus Lifesciences Inc.
- Reason
- Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- cGMP deviations: The firm was notified of the manufacturer's expanded recall.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
by KVK-Tech, Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
- Published
- January 20, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032
by US Compounding Inc
- Reason
- Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
by Sunstar Americas, Inc.
- Reason
- cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
by Akorn, Inc.
- Reason
- Defective container: Customer complaints for oral solution leaking from bottles.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- 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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