RecallRadar

FDA Drug recall D-1567-2014

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only

On 2014-09-03 the FDA classified a Class II recall of Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only by Pharmakon Pharmaceuticals, citing incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1567-2014
ClassificationClass II
Statusterminated
Initiated2014-04-21
Published2014-09-03
Last updated2026-09-13 11:51 UTC
CompanyPharmakon Pharmaceuticals
DistributionIL, IN, MD, TX

Product

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.

Reason

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Identifiers

code_infoLot #: E131210.212 Exp: 07/14/2014

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-1567-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.