Recalls / Class II
Class IID-0546-2016
Product
Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Affected lot / code info
- All lots within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Walgreens Infusion Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14220 Northbrook Dr Ste 100B, N/A, San Antonio, Texas 78232-5045
Distribution
- Quantity
- 21 syringes
- Distribution pattern
- Texas
Timeline
- Recall initiated
- 2015-11-10
- FDA classified
- 2015-12-30
- Posted by FDA
- 2016-01-06
- Terminated
- 2017-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0546-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.