Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-06-15FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IITopex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
cGMP deviations: Temperature abuse
- 2022-06-15FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IITobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
cGMP deviations: Temperature abuse
- 2022-06-15FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIMiocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20
cGMP deviations: Temperature abuse
- 2022-06-15FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIEPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
cGMP deviations: Temperature abuse
- 2022-06-15FDA-DrugGrato Holdings, Inc.Class IIEarache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Microbial contamination of non-sterile product.
- 2022-06-15FDA-DrugGrato Holdings, Inc.Class IIHomeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
Microbial contamination of non-sterile product.
- 2022-06-15FDA-DrugGrato Holdings, Inc.Class IIHomeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
Microbial contamination of non-sterile product.
- 2022-06-15FDA-DrugTeva Pharmaceuticals USA IncClass IIIAlprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- 2022-06-15FDA-DrugUS Specialty Formulations LLCClass IIB-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
Lack of Assurance of Sterility
- 2022-06-15FDA-DrugUS Specialty Formulations LLCClass IIEthanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
Lack of Assurance of Sterility
- 2022-06-15FDA-DrugNovartis Pharmaceuticals CorporationClass IIIXiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Failed Impurities/Degradation Specifications.
- 2022-06-15FDA-DrugNovartis Pharmaceuticals CorporationClass IIIXiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
Failed Impurities/Degradation Specifications.
- 2022-06-15FDA-DrugNovartis Pharmaceuticals CorporationClass IIIXiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Failed Impurities/Degradation Specifications.
- 2022-06-15FDA-DrugNovartis Pharmaceuticals CorporationClass IIIXiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
Failed Impurities/Degradation Specifications.
- 2022-06-08FDA-DrugTeva Pharmaceuticals USA IncClass IAnagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IIAveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IILuxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IILuxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IIAMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g)
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IIAMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g)
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IIAMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IIOnly At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL)
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugStrides Pharma Inc.Class IILosartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-08FDA-DrugStrides Pharma Inc.Class IILosartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-08FDA-DrugStrides Pharma Inc.Class IILosartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-08FDA-DrugDirect RxClass IILosartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-08FDA-DrugVi-Jon, LLCClass IIEquate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IISuccinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIRocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIPhenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Lack of Assurance of Sterility
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