FDA Recall
Terminated
Historical recordClass II
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- cGMP deviations: Temperature abuse
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
by Grato Holdings, Inc.
- Reason
- Microbial contamination of non-sterile product.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
by Grato Holdings, Inc.
- Reason
- Microbial contamination of non-sterile product.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
by Grato Holdings, Inc.
- Reason
- Microbial contamination of non-sterile product.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
by US Specialty Formulations LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
by US Specialty Formulations LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE MILK CHOCOLATE HEARTS UPC:73490154485
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The TJX Companies, Inc.
- Product
- Keats London Vegan Irish Cream Truffles in a 4.93-ounce rou…
- Reason
- Product(s) may contain undeclared milk.
- Published
- June 15, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The TJX Companies, Inc.
- Product
- Keats London Vegan Hazelnut Dark Chocolate in a 4.93-ounce…
- Reason
- Product(s) may contain undeclared milk.
- Published
- June 15, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The TJX Companies, Inc.
- Product
- Pimlico Confectioners Vegan Fine Hazelnut Truffles in a 3.8…
- Reason
- Product(s) may contain undeclared milk.
- Published
- June 15, 2022
- Distribution
- Multiple states
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.
Read the full medical disclaimer.