Drug product
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
D-0322-2015
Product summary
- Event
- Event 69945
- Status
- Terminated
- Classification
- Class III
- Quantity
- 71904 Bottles
- Official record key
drug-enforcement:D-0322-2015
Official wording
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Code information: Lot #: 3A450, Expiry: 01/06.
Distribution pattern: U.S. Nationwide and Canada (Ontario).
Derived failure modes
-
Manufacturing or process control
CGMP Deviations