RecallRadar

FDA Drug recall D-1231-2016

NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

On 2016-07-20 the FDA classified a Class II recall of NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY by Medaus, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1231-2016
ClassificationClass II
Statusterminated
Initiated2016-05-13
Published2016-07-20
Last updated2026-09-13 11:51 UTC
CompanyMedaus
DistributionUS

Product

NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Reason

Lack of Assurance of Sterility

Identifiers

code_info
a) Lot #: 160204-29, BUD: 08/02/16. b) Lot #: 151123-73, BUD: 05/21/16; Lot #: 151124-42, BUD: 05/22/16; Lot #: 1512…a) Lot #: 160204-29, BUD: 08/02/16. b) Lot #: 151123-73, BUD: 05/21/16; Lot #: 151124-42, BUD: 05/22/16; Lot #: 151201-20, BUD: 05/29/16; Lot #: 151215-10, BUD: 06/12/16; Lot #: 160229-46, BUD: 07/17/16; Lot #: 160202-33, BUD: 07/31/16. c) Lot #: 160315-9, BUD: 09/11/16.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1231-2016%22

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