Drug product
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
D-0531-2020
Product summary
- Event
- Event 84359
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0531-2020
Official wording
Reason: Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Code information: Lot #: I1718U, Exp. 3/2020; K0818L, Exp. 9/2020; L2718E, Exp. 9/2020; A2219E, Exp. 9/2020; C1519S, Exp. 12/2020; C2819Y, Exp. 12/2020; E2019V, Exp. 11/2020
Distribution pattern: CA, FL, IL
Derived failure modes
-
Foreign material or chemical contamination
foreign substance