FDA Recall
Terminated
Historical recordClass III
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
by GlaxoSmithKline LLC
- Reason
- Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints exceeded respective action limits.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
by Direct Rx
- Reason
- CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
H-E-B Grocery Company, LP DBA HEB Milk & Culture Plant #80645
- Product
- HEB Bakery Simply Delicious Cookies with Brownie Bites Party…
- Reason
- potential metal fragments in product
- Published
- June 1, 2022
- Distribution
- Texas
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colewillaidan LLC
- Product
- Cole's Select Curry Salmon Rice Bowl, Green Curried Salmon O…
- Reason
- Salmon curry bowl ingredients does not declare Salmon ingredient or soy.
- Published
- June 1, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
H-E-B Grocery Company, LP DBA HEB Milk & Culture Plant #80645
- Product
- HEB Bakery Two-Bite Brownies NET WT 12 OZ (340g) UPC 0471220…
- Reason
- potential metal fragments in product
- Published
- June 1, 2022
- Distribution
- Texas
View recall →
FDA Recall
Terminated
Historical recordClass III
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
by Apotex Corp.
- Reason
- Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specification
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
T Fresh Company DBA Yes Produce
- Product
- Yes! Enoki Mushrooms; Pesticide Free Produce: Vacuumed pack…
- Reason
- California Department of Public Health sampled product with a result of Listeria monocytogenes
- Published
- May 25, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Driscoll's Inc.
- Product
- Driscoll's Blackberries (Fresh) 12x6 oz, 12x12 oz, 12x10 oz…
- Reason
- California Department of Pesticide Regulation detected the presence of Formetante HCI. This pesticide has a non-tolerance for blackberries.
- Published
- May 25, 2022
- Distribution
- Product shipped to 13 DC's located in CA…
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
- Published
- May 18, 2022
- 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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