Recalls / Class II
Class IID-0531-2020
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
- Affected lot / code info
- 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
Why it was recalled
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Distribution pattern
- CA, FL, IL
Timeline
- Recall initiated
- 2019-11-21
- FDA classified
- 2019-11-27
- Posted by FDA
- 2019-12-04
- Terminated
- 2023-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0531-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.