Recalls / Class II
Class IID-1403-2014
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234
- Affected lot / code info
- a) 5 mL: Lot: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14;
Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recalling firm
- Firm
- John W Hollis Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 110 20th Ave N, N/A, Nashville, Tennessee 37203-2315
Distribution
- Quantity
- 40 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-12
- FDA classified
- 2014-06-18
- Posted by FDA
- 2014-06-25
- Terminated
- 2014-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1403-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.