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
Pizza Blends, LLC
- Product
- Paul Revere's Pizza, Pizza Crust Mix, Manufactured by Pizza…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- CEC Entertainment, Inc., Proprietary Pizza Dough Premix, Man…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- CEC Entertainment, Inc., No Yeast Proprietary Pizza Dough Pr…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- Village Pizza & Seafood, Custom Pizza Flour, Manufactured Ex…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- Very Good Foods, Complete Round Dough Mix, Manufactured Excl…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- Peter Piper, Two-N-One Dough, Manufactured Exclusively for P…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- The Great American by Pizza Blends, Pizza Dough Mix No Yeast…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- FourStar Pizza & Subs, Pizza Dough Premix, Manufactured by P…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- Chicago's Pizza Base Mix, Manufactured Exclusively for Chica…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
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
🇺🇸 United States
Terminated
Historical recordClass I
Pizza Blends, LLC
- Product
- The Great American by Pizza Blends, Pizza Dough Mix With Yea…
- Reason
- The firm received an ingredient from their supplier that is potentially contaminated with Salmonella.
- Published
- February 13, 2019
- Distribution
- Distributed to customers in AR, CO, FL,…
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 →
FDA Recall
Terminated
Historical recordClass II
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- 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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