Results 1 to 1 of 1
04-12-2013, 05:32 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
Tetracycline HCL Capsules USP 250 mg recalled pending classification
Tetracycline HCL Capsules Recalled "pending classification"*
Pending recall for the March 27th, 2013 Enforcement Report
PRODUCTTetracycline HCL Capsules USP 250 mg
CODE69MO EXP 05/31/2013, 69SH EXP 05/31/2013, 5KXZ EXP 05/31/2012, 5RE1 EXP 05/31/2012
RECALLING FIRMPhysicians Total Care, Inc., Tulsa OK
REASON FOR RECALLPresence of Particulate Matter; sub-recall from the manufacturers initiated recall due to the potential for particulate matter in the Active Pharmaceutical Ingredient (API).
Human Drug Product Recalls Pending Classification
FDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action.
The information will be continue to be provided in a narrative format until FDA has decided upon the method to include it in the new Enforcement Report format. They will be reposted with their classification in the Enforcement Report once that determination has been made
Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.