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D-0932-2022 Class II

Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy — Orlando, FL

FDA drug recall D-0932-2022 was initiated by Olympia Compounding Pharmacy dba Olympia Pharmacy on May 9, 2022 and is designated Class II. Reason for recall: Lack of assurance of sterility. Affected quantity: 3762 vials.

Recall Details

Product Type
Drugs
Report Date
June 1, 2022
Initiation Date
May 9, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3762 vials

Product Description

Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reason for Recall

Lack of assurance of sterility.

Distribution Pattern

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Code Information

Lots: A24103 BUD: 7/3/2022; B41B01-22 BUD: 8/1/2022

Other recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy

  • D-0903-2022 Class II — Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica (May 9, 2022)
  • D-0934-2022 Class II — Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg (May 9, 2022)
  • D-0928-2022 Class II — Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropin (May 9, 2022)
  • D-0949-2022 Class II — Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lys (May 9, 2022)
  • D-0905-2022 Class II — Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutic (May 9, 2022)
  • D-0940-2022 Class II — NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL (May 9, 2022)
  • D-0925-2022 Class II — FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 m (May 9, 2022)
  • D-0904-2022 Class II — Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia (May 9, 2022)
  • D-0901-2022 Class II — SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL (May 9, 2022)
  • D-0916-2022 Class II — Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutica (May 9, 2022)

FDA data resources