Recalls / Class II
Class IID-0227-2023
Product
PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Affected lot / code info
- t20221025@7 t20221116@36 20221114@41 t20221117@5 t20221116@36
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recalling firm
- Firm
- Pharmacy Innovations
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2936 W 17th St, N/A, Erie, Pennsylvania 16505-3929
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2023-01-26
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0227-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.