RecallRadar

FDA Drug recall D-1002-2016

METHYLCOBALAMIN/FOLIC ACID

On 2016-06-15 the FDA classified a Class II recall of METHYLCOBALAMIN/FOLIC ACID by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1002-2016
ClassificationClass II
Statusterminated
Initiated2016-05-17
Published2016-06-15
Last updated2026-09-13 11:51 UTC
CompanyWell Care Compounding Pharmacy
DistributionNV

Product

METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Identifiers

code_info
Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 0…Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016.

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-1002-2016%22

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