Agency classClass IIOur severity:High FDA (Drugs)·D-0815-2021·Announced 2021-09-29

Promethazine With Codeine Oral Solution Recall Due to Microbial Contamination

Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution (Lot #UV1198) nationwide due to potential microbial contamination in liquid sugar batches used during manufacturing.

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 3/5 (High).

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: The source states a CGMP deviation involving potential microbial contamination in a liquid sugar ingredient used to manufacture an oral pharmaceutical product. This represents a risk-of-harm concern for contaminated drug products. The source text does not report any confirmed illnesses or injuries, making this a theoretical hazard that does not qualify as Severe (score 4) but warrants a High rating due to the nature of microbial contamination in a drug intended for internal use.

Plain-English summary

Morton Grove Pharmaceuticals, Inc. is recalling Promethazine With Codeine Oral Solution containing Promethazine Hydrochloride 6.25 mg/5mL and Codeine Phosphate 10 mg/5 mL in 1-pint (473 mL) bottles (NDC: 60432-606-16, Lot #UV1198). The product was manufactured for Wockhardt USA, LLC.

The recall is being issued due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, there is a potential concern that products were manufactured using liquid sugar batches contaminated with microbial organisms.

Approximately 14,904 bottles have been distributed nationwide in the USA and to China. This is a prescription-only medication. Consumers who have this product should contact their pharmacy or healthcare provider for guidance on whether they have affected units.

The recalled product

Product: Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053.…
Manufacturer: Morton Grove Pharmaceuticals, Inc.
Category: Drug — Oral Solution / Promethazine-Codeine
Hazard: microbial-contamination
cgmp-deviation
Affected units: 14,904

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 (1)

Lot #: UV1198

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Morton Grove Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Morton Grove Pharmaceuticals, Inc.

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Same hazard · microbial contamination