Home / Recalls / Olympia Compounding Pharmacy dba Olympia Pharmacy / D-0936-2022

D-0936-2022 Class II

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

FDA drug recall D-0936-2022 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: 12800 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: 12800 vials

Product Description

Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, 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: L24122, L24C22, L24B22 BUD: 6/22/2022, A24124-22 BUD: 7/24/2022, A24225-22 BUD: 7/25/2022, A24026-22 BUD: 7/26/2022, A24027-22 BUD: 7/27/2022, A24C31-22, A24B31-22 BUD: 7/31/2022

Other recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy

D-0930-2022 Class II — Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceutical (May 9, 2022)
D-0900-2022 Class II — SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vi (May 9, 2022)
D-0923-2022 Class II — Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, (May 9, 2022)
D-0919-2022 Class II — AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 (May 9, 2022)
D-0937-2022 Class II — MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalam (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)
D-0926-2022 Class II — Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Oly (May 9, 2022)
D-0931-2022 Class II — Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia P (May 9, 2022)
D-0918-2022 Class II — Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharm (May 9, 2022)
D-0945-2022 Class II — Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6 (May 9, 2022)