D-1411-2019 Class II Terminated
FDA drug recall D-1411-2019 was initiated by Premier Pharmacy Labs Inc on June 18, 2019 and is designated Class II. 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 st… The recall status is terminated (terminated October 26, 2021). Affected quantity: 745 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2019
- Initiation Date
- June 18, 2019
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 745 syringes
Product Description
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 Pattern
Nationwide in the USA
Code Information
All lots remaining within expiry.