FDA recalls: January 2019
Every food and drug recall report the FDA published in January 2019: 78 reports, 22 of them Class I.
- Recall reports
- 78
- Class I (serious)
- 22
- Food
- 19
- Drugs
- 59
- Jan 30, 2019curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe A…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syr…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LL…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safet…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 20195K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Togethe…Drug · Happy Together, Inc.Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafilClass I
- Jan 30, 2019Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufacture…Drug · Dr. Reddy's Laboratories, Inc.Presence of Foreign Substance: Product complaint of black speckles observed on tablets.Class II
- Jan 30, 2019Fluocinolone Acetonide Topical Solution, USP, 0Drug · LUPIN SOMERSETFailed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of…Class II
- Jan 30, 2019LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distribu…Drug · Sun Pharmaceutical Industries, Inc.Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.Class III
- Jan 30, 2019HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0Drug · Advanced Pharma Inc.Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)Class II
- Jan 30, 2019Del Monte Quality Fresh Cut Harvest Selects Fiesta Corn seasoned with Red & Green PeppersFood · Del Monte Research Center - Walnut CreekRecord review found the several productions runs were processed using the incorrect thermal process, and therefore the potential for Clostridium botulinum.Class II
- Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactu…
- Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactu…
- Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactur…
- Amlodipine and Valsartan Tablets USP 10 mg/320 mg
- Valsartan and Hydrochlorothiazide tablets USP 320mg/12
- Valsartan and Hydrochlorothiazide tablets USP 160mg/12
- Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only,…
- Valsartan and Hydrochlorothiazide tablets USP 80 mg/12
- Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, M…
- Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Ph…
- curaplex Epi Safe Administration and Training Kits # 8600-01100
- EEMT HS (esterified estrogens and methyltestosterone) 0
- EEMT (esterified estrogens and methyltestosterone) 1
- Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe,…
- Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactur…
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-co…
- Hiland Chocolate Milk, 1/2 gallon (1
- Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-…
- Dianeal Low Calcium (2
- Cidofovir Injection 375mg/5mL (75mg/mL) vial injection
- Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-61…
- Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-62…
- Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-0…
- Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01)…
- Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilize…
- Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized…
- 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD S…
- Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)…
- Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)…
- OZURDEX (dexamethasone intravitreal implant) 0
- Adam Bros
- Adam Bros
- Adam Bros
- Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by:…
- Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
- Epinephrine liquid 1:1000, RX, glass vial
- Glutathione liquid, 100mg/ml
- HCG liquid, 1000u/ml, RX, glass vial, various
- Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
- Lidocaine gel 2%, RX, plastic dropper
- Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable me…
- MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
- Methocarbamol liquid 100mg/ml, RX, glass vial
- Testosteron Cypionate liquid 200mg/ml, RX, glass vial
- Vitamin B12 liquid 1000mcg/ml, RX, glass vial
- Cyclosporin liquid 1%, Rx, plastic dropper bottle
- Cyclosporin liquid 0
- Cyclosporin liquid 0
- Cyclosporin liquid 0
- Glutathione liquid, 200mg/ml, Rx
- Lidocaine gel 1%, RX, plastic dropper
- Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 cou…
- Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason…
- Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1…
- Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand
- Frozen Unbreaded Egg, 3 Cheese and caramelized onion
- Frozen Unbreaded Egg, Gouda, caramelized onion
- Frozen Unbreaded French onion / Swiss and Onion CC
- ROOT 23 CUCUMBER HABANERO SIMPLE SYRUP 375 ml
- El Super Leon Jabalina Xtreme 50 pieces Net Wt
- 1) PICA-BOLA 50 pieces Cont
- FLECHAZO 36 pieces Net Wt
- Tamy Pop 18 pieces Net Wt
- Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique
- Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5
- Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5
- Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5
- Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5
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