FDA recall D-1411-2019

Product

Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.

Reason for recall

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-06-18

Report date

2019-07-03

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weeki Wachee, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2019