Ibuprofen Oral Suspension Recalled for Inert Plastic Particles
Preferred Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP due to the presence of small particles of inert plastic material.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling specific lots of Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only. The affected product is manufactured by Taro Pharm. in Hawthorne, NY, and distributed in California, Florida, and Illinois.
The recall was initiated because the medication may contain small particles of an inert plastic material that were introduced during the manufacturing process. The affected lots include I1718U, K0818L, L2718E, A2219E, C1519S, C2819Y, and E2019V, with expiration dates ranging from March 2020 to December 2020.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Category
- Drug — Oral Suspension
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: I1718U
- Exp. 3/2020
- K0818L
- Exp. 9/2020
- L2718E
- A2219E
- C1519S
- Exp. 12/2020
- C2819Y
- E2019V
- Exp. 11/2020
Distribution
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