Children's ibuprofen suspension recalled over gel-like mass and black particles
Strides Pharma is recalling two lots of Children's Ibuprofen Oral Suspension after complaints of a gel-like mass and black particles in the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: complaints confirm foreign material in a medicine given to children, and no injuries or illnesses are stated in the source.
Plain-English summary
Strides Pharma Inc is recalling Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, in 4 fl oz (120 mL) bottles, made in India for Taro Pharmaceuticals U.S.A., Inc. of Hawthorne, New York, NDC 51672-5321-8. About 89,592 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for the presence of a foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Affected product covers lots 7261973A and 7261974A, both with an expiry date of 01/31/2027.
Parents and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Strides Pharma Inc for further information.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- STRIDES PHARMA INC
- Affected units
- 89,592
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 (3)
- Lot: 7261973A
- 7261974A
- Exp 01/31/2027
UPCs (1)
- 0351672532185
Distribution
Distributed nationwide across the United States.
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