FDA Recall
Ongoing
Historical recordClass II
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
by Denison Pharmaceuticals, LLC
- Reason
- CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
by Denison Pharmaceuticals, LLC
- Reason
- CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vital Proteins
- Product
- Vital Proteins Collagen Peptides, retail 24oz plastic canist…
- Reason
- potential foreign material contamination (pieces of one blue broken lid may be in one or more canisters)
- Published
- June 7, 2023
- Distribution
- Distributed to retail locations in the f…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The H.T. Hackney Company
- Product
- Fresh location Caesar Salad, 6.00oz clear plastic container,…
- Reason
- Potential for metal in product
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The H.T. Hackney Company
- Product
- Fresh location Garden Salad with Ranch, 7.25oz clear plastic…
- Reason
- Potential for metal in product
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The H.T. Hackney Company
- Product
- Fresh location Chef Salad with Ranch, 8.75oz clear plastic c…
- Reason
- Potential for metal in product
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The H.T. Hackney Company
- Product
- Fresh location Turkey Caesar Salad, 7.5oz clear plastic cont…
- Reason
- Potential for metal in product
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The H.T. Hackney Company
- Product
- Fresh location Apple Cranberry Walnut Salad, 7.5oz clear pla…
- Reason
- Potential for metal in product
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Regal Trading, Inc.
- Product
- Trader Joes Instant Cold Brew Coffee, 3.5 oz.(99g), 24 jars…
- Reason
- Presence of foreign material (glass particles) in product.
- Published
- June 7, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
by Revive Rx LLC dba Revive Rx Pharmacy
- Reason
- Sub-potent Drug
- Published
- May 31, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
by Teva Pharmaceuticals USA Inc
- Reason
- Labeling: Incorrect or Missing Package Insert
- Published
- May 31, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
by Teva Pharmaceuticals USA Inc
- Reason
- Labeling: Incorrect or Missing Package Insert
- Published
- May 31, 2023
- 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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