FDA Recall
Terminated
Historical recordClass II
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
by Promise Pharmacy, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Sunflower Butter 16 oz. SKU/UPC 671635704825
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Organic Coconut Butter 16 oz. SKU/UPC 671635…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Creamy Cashew Butter 16 oz. SKU/UPC 671635704…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Sesame Tahini 16 oz. SKU/UPC 671635704795
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Organic Creamy Peanut Butter 16 oz. SKU/UPC…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Organic Crunchy Peanut Butter 16 oz. SKU/UPC…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Non-GMO Crunchy Almond Butter 16 oz. SKU/UPC…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Organic Crunchy Almond Butter 16 oz. SKU/UPC…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Non-GMO Creamy Almond Butter 16 oz. SKU/UPC 6…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
THRIVE MARKET
- Product
- Thrive Market Organic Almond Butter Creamy 16 oz. SKU/UPC 6…
- Reason
- Potential Listeria monocytogenes contamination.
- Published
- February 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
by US Pharmaceuticals Inc.
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
by Mylan Pharmaceuticals Inc.
- Reason
- Defective Container: Potential for broken glass in the neck area of the glass bottles.
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Funky Chunky LLC
- Product
- Nutty Choco Pop, 10 oz. bag. Sold in the following configur…
- Reason
- Nutty Choco Pop has in incorrect label and does not declare that it contains cashews and almonds.
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
by Sun Pharmaceutical Industries, Inc.
- Reason
- Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
by H J Harkins Company Inc dba Pharma Pac
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
- Published
- February 6, 2019
- 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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