Recalls / Class II
Class IID-0185-2017
Product
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12
- Affected lot / code info
- Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017
Why it was recalled
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 30,796 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-18
- FDA classified
- 2016-12-13
- Posted by FDA
- 2016-12-21
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0185-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.