Class II · Moderate risk Ongoing
Bicillin L-A
Reason CGMP Deviations; particulates identified during visual inspection
Pfizerpen
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
What was recalled
Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1455-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Penicillin recalls
See all
Class I · High risk Ongoing
Buffered Penicillin G Potassium for Injection
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class II · Moderate risk Terminated
Bicillin L-A
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Penicillin
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Penicillin V Potassium for Oral Solution
Reason Subpotent
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