FDA Recall
Terminated
Historical recordClass II
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: Particulates observed in vials release for dispensing.
- Published
- February 5, 2020
- Distribution
- Prescriptions filled for patients in the…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Truong Phu Xanh Co.,
- Product
- Frozen Yellowfin Tuna, Product of Vietnam, Packaged under t…
- Reason
- Elevated histamine levels.
- Published
- February 5, 2020
- Distribution
- Direct Distribution to FL, RI, CA, NJ
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jeni's Splendid Ice Creams LLC
- Product
- Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen…
- Reason
- May contain undeclared milk allergen
- Published
- February 5, 2020
- Distribution
- Product distributed to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ingredion Incorporated
- Product
- Ingredion ULTRA-TEX4 Food Starch in 50lb paper bags, product…
- Reason
- Foreign material. Potential for fragments of stainless steel wire in the product. Fragments are approximately 0.19mm in diameter with varying lengths of 1mm 20mm in length.
- Published
- February 5, 2020
- Distribution
- CA, GA, IL, MN, MO, NC, NJ, OH Australi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich…
- Reason
- Potential to contain undeclared milk and coconut.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes…
- Reason
- Potential to contain undeclared milk.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
by Tuscano and Delucia Group (DBA Entropic Labs)
- Reason
- Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
by Advanced Accelerator Applications USA, Inc.
- Reason
- Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
by AuroMedics Pharma LLC
- Reason
- Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 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.
Read the full medical disclaimer.