Recalls / Class II
Class IID-0025-2017
Product
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
- Affected lot / code info
- Lot Numbers: 15146085M, 15147088M, 15149011M, 15149109M, 15150093M, 151730001M, 151740139M, 151900018M, 151910014M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 4407 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0025-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.