FDA Recall
Terminated
Historical recordClass II
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
by Paddock Laboratories, LLC.
- Reason
- Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
by Renaissance Lakewood, LLC
- Reason
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Piggie Park Enterprises Inc
- Product
- Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bott…
- Reason
- Undeclared soy and wheat ingredients
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Ikea North America Srvcs Inc
- Product
- Pink flexible, plastic package: Godis Paskkyckling Marshm…
- Reason
- Possible Pest Contamination at production facility.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Food and Beverage Inc.
- Product
- Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Wei…
- Reason
- Food & Beverage Inc., dba Chris's Cookies has initiated a recall of Trader Joe s Peanut Butter Sutter s Formula Cookies (Trader Joes SKU 93307) that was packed in a Trader Joes branded Chocolate Chip Cookie bag, and sent out as Chocolate Chip Cookies. Please note the Chocolate Chip Cookie bag has a statement on the back that says: MAY CONTAIN TRACES OF PEANUTS AND TREE NUTS , but since the wrong product packed is based almost completely in peanut this could represent a bigger risk for those who have peanuts allergies. Thus, prompting the firm to error on the side of public safety and initiate a recall.
- Published
- March 28, 2018
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
Terminated
Historical recordClass II
Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30
by Hetero Labs Limited Unit V
- Reason
- Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
by Hetero Labs Limited Unit V
- Reason
- Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
by Novel Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
by Pfizer Inc.
- Reason
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
by Pfizer Inc.
- Reason
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
by American Pharmaceutical Ingredients LLC
- Reason
- Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
by American Pharmaceutical Ingredients LLC
- Reason
- Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
by Alva-Amco Pharmacal Companies., Inc.
- Reason
- Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
by Sagent Pharmaceuticals Inc
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
by Sagent Pharmaceuticals Inc
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
by Sagent Pharmaceuticals Inc
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Plant Devas Inc
- Product
- Ayurvedic Face Care Kit; Each kit contains: Coconut Cream…
- Reason
- FDA Office of Colors and Cosmetics sampled product and found virulent and excessive numbers of microorganisms.
- Published
- March 21, 2018
- 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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