FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakuku FISH CAKE MINCH BALL SK F; 20/ 150G; Net Wt. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE BOUTEN SK F 20/ 150G, Net Wt. 5.29 oz.…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE IWASHI TEN SK F 20/150 g; Net WT. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Mott's LLP
- Product
- Penafiel Mineral Spring Water 600mL (20.3 FL OZ) and Penafie…
- Reason
- Elevated levels of inorganic arsenic
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
by Piramal Critical Care, Inc.
- Reason
- Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
by LNK International, Inc.
- Reason
- Microbial contamination of non-sterile product
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
by MAJOR PHARMACEUTICALS
- Reason
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
by ImprimisRx NJ
- Reason
- Subpotent Drug
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
by ImprimisRx NJ
- Reason
- Subpotent Drug
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
by Wise Pharmacy
- Reason
- Lack of Processing Controls
- Published
- August 7, 2019
- Distribution
- Multiple states
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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