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.
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIFentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIMethylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IILorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIKetamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIMorphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIVancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IITrimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IITrimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIHydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIHydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIHydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIHydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugB. Braun Medical, Inc.Class II0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Lack of sterility assurance: leaking bags
- 2022-03-23FDA-DrugGolden State Medical Supply Inc.Class IIAlprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
- 2022-03-23FDA-DrugThe Harvard Drug GroupClass IIhydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- 2022-03-16FDA-DrugAmerican Health PackagingClass IIOxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
Impurity failure at 0-time of the repackaged lot.
- 2022-03-16FDA-DrugDirect RxClass IIAlprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- 2022-03-16FDA-DrugDirect RxClass IIAlprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- 2022-03-16FDA-DrugThe Harvard Drug GroupClass IIPALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
Failed Dissolution Specifications
- 2022-03-09FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIDexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
- 2022-03-09FDA-DrugVi-Jon, Inc.Class IIHEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
- 2022-03-09FDA-DrugPreferred Pharmaceuticals, Inc.Class IIAlprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
CGMP deviations
- 2022-03-09FDA-DrugDollar Tree Distribution, Inc.Class IIAll Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
- 2022-03-09FDA-DrugMacleods Pharma Usa IncClass IIOlanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
cGmp Deviations
- 2022-03-09FDA-DrugDirect RxClass IIMoxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Failed impurities/degradation specifications
- 2022-03-09FDA-DrugTsm Brands LLCClass IILuxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Labeling - product contains undeclared ethyl alcohol
- 2022-03-09FDA-DrugTsm Brands LLCClass II70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
Labeling - product contains undeclared ethyl alcohol
- 2022-03-09FDA-DrugMacleods Pharma Usa IncClass IIAmlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
cGMP deviations
- 2022-03-02FDA-DrugAMS Packaging IncClass IIPremium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
- 2022-03-02FDA-DrugAMS Packaging IncClass IIPremium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
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