FDA Recall
Terminated
Historical recordClass I
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
by Gilead Sciences, Inc.
- Reason
- Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
by Teligent Pharma, Inc.
- Reason
- Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
by Teligent Pharma, Inc.
- Reason
- Superpotent Drug: Minimally superpotent
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
by Teligent Pharma, Inc.
- Reason
- Superpotent Drug
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Slayer Forever, LLC dba BUBS Naturals
- Product
- BUBS Naturals Fountain of Youth Formula; Collagen Protein; S…
- Reason
- Supplement contains undeclared milk from MCT oil powder ingredient.
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
by Teva Pharmaceuticals USA
- Reason
- Subpotent
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06
by Efficient Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
by The Harvard Drug Group
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
by Medline Industries Inc
- Reason
- Defective Container: Customer complaints for leaking bottles and dispensing issues.
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dakota Tom's, Inc
- Product
- Dakota Tom's and Market Fresh branded Chicken Salad Croissan…
- Reason
- Sandwiches contain undeclared egg and milk.
- Published
- December 29, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cooki…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cooki…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Kimberley's bakeshoppe Frosted soft Sugar Cookies 13.5 oz. U…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Favorite Day Bakery Frosted Sugar Cookies 13.5 oz. UPC 0 852…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Wondershop at Target Frosted Sugar Cookies 13.5 oz. UPC 0 85…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GIVE AND GO
- Product
- Favorite Day Bakery madeleine & brownie tiny treats 11 oz. U…
- Reason
- Potential for metal in product
- Published
- December 29, 2021
- 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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