Status
Terminated
Drug Enforcement D-050-2013
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Classification
Class III
Report Date
November 21, 2012
Termination Date
January 31, 2013
Product Information
- Product description
- Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
- Product quantity
- 22 units
- Reason for recall
- Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- FL, PA, and VA.
Location & Firm
- Recalling firm
- Stat Rx USA
- Address
-
2481 Hilton Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-050-2013
- Event ID
- 62940
- Recall initiation date
- June 18, 2012
- Center classification date
- November 9, 2012
- Code info
- Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
- More code info
- —