Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.
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 FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in 8 fl oz (237 mL) bottles. The product is prescription-only and was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the product failed impurity/degradation specifications, specifically for Prednisolone Impurity 14. The affected lots are US1450 (Exp 10/31/19), US1570 (Exp 12/31/19), UT1018 (Exp 1/31/19), UT1173 (Exp 6/30/20), UT1348, and UT1354 (Exp 8/31/20). A total of 196,408 bottles are involved in this recall.
The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 196,408
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 #: US1450
- Exp 10/31/19
- US1570
- Exp 12/31/19
- UT1018
- Exp 1/31/19
- UT1173
- Exp 6/30/20
- UT1348
- UT1354
- Exp 8/31/20
Distribution
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