FDA Recall
Terminated
Historical recordClass II
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
by Spectrum Laboratory Products
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- February 12, 2020
- Distribution
- The recalled API was distributed to phar…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
by Pharmaceutical Associates Inc
- Reason
- Subpotent: Out of specification for assay at the 12-month time point.
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
by Macleods Pharma Usa Inc
- Reason
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
by Shandex Personal Care Manufacturing Inc.
- Reason
- Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
- Published
- February 5, 2020
- Distribution
- Nationwide
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…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Healthy Food Ingredients, LLC
- Product
- Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and…
- Reason
- Product is being recalled due to detection of an unapproved herbicide.
- Published
- February 5, 2020
- Distribution
- CA, CO, UT. EXPANDED February 2020: M…
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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
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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 →
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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